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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database

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N = 538
n = 489 with New Pediatric Studies; n = 49 with No New Pediatric Studies
BPCA only = 161; BPCA + PREA = 73; PREA only = 254; Rule = 49; None = 1

Pediatric Labeling Changes as of November 17,2014

This list highlights key pediatric information from the studies submitted in response to pediatric legislative initiatives. CBER regulated products have an asterisk (*) by the proper name. To obtain all the information for a pediatric labeling change, select the pediatric labeling date in the first column of the database to reveal the additional information. To view all records in the database, select the All button at the bottom of the page. To search for a specific pediatric labeling change, enter the trade name or generic name in the Filter box and select Show Items. Note: CBER and CDER regulated biologics with pediatric labeling changes before 9/27/2007 are excluded from the database.
Download New Pediatric Labeling Information Database data in Microsoft Excel web format  Click on this link to download all data from the selected searchable database in Excel format. If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players .



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   No. of Records Found:  538
Pediatric Labeling Date Trade Name Generic Name or Proper Name (*) Indications Studied Label Changes Summary Therapeutic Category
10/29/2014 Trumenba Meningococcal Group B Vaccine* Active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B See Package Insert for new information on biologics Vaccine
09/12/2014 RIXUBIS Coagulation Factor IX (Recombinant)* Control and prevention of bleeding episodes, perioperative management, and routine prophylaxis See Package Insert for new information on biologics Coagulant
08/29/2014 Taclonex calcipotriene/ betamethasone dipropionate Plaque psoriasis of the scalp *Expanded the indication from adults to pediatric patients 12 – 17 years * Safety and effectiveness have not been established in pediatric patients less than 12 years * In a trial to evaluate the effect on HPA axis suppression in pediatric patients 12 – 17 years, adrenal suppression was identified in 1 of 30 patients (3.3%) after 4 weeks of treatment * Rare systemic toxicities such as Cushing’s syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in pediatric patients, especially those with prolonged exposure to large doses of high potency topical corticosteroids *Local adverse reactions including striae have also been reported with use of topical corticosteroids in pediatric patients * Information on dose and maximum weekly dose, adverse reactions, and clinical trials * Postmarketing study Anti-inflammatory, topical
08/20/2014 Arnuity Ellipta fluticasone furoate Maintenance treatment of asthma as prophylactic therapy * Approved for use in adults and pediatric patients 12 years and older * Safety and efficacy in pediatric patients younger than 12 years have not been established * Orally inhaled corticosteroids may cause a reduction in growth velocity when administered to children and adolescents. The growth of children and adolescents receiving orally inhaled corticosteroids, including Arnuity Ellipta, should be monitored routinely. The potential growth effects of prolonged treatment should be weighed against the clinical benefits obtained and the risks associated with alternative therapies * Information on safety, adverse events and clinical trials * New dosage form Antiasthmatic
08/01/2014 Keppra XR levetiracetam Adjunctive therapy in the treatment of partial onset seizures * Safety and effectiveness in pediatric patients 12 years and older have been established based on PK data in adults and adolescents using Keppra XR and efficacy and safety data in pediatric studies using immediate-release Keppra * Safety and effectiveness of in patients below the age of 12 years have not been established * Information on PK parameters and PK study *Postmarketing study Anticonvulsant
07/03/2014 Namenda XR memantine hydrochloride Autism spectrum disorders *The safety and effectiveness of memantine have not been established in pediatric patients *Memantine failed to demonstrate efficacy in two 12-week controlled clinical studies of 578 pediatric patients aged 6-12 years with autism spectrum disorders *Adverse reactions were similar to those observed in adults* Information on dosing, adverse reactions, clinical trials
06/09/2014 Abilify aripiprazole Maintenance treatment of irritability associated with autistic disorder *Efficacy for the maintenance treatment of irritability associated with autistic disorder was not established in a 12 week clinical trial in 85 pediatric patients 6-17 years * Information on clinical trial* Postmarketing study Antipsychotic
06/02/2014 Reyataz atazanavir Treatment of HIV - 1 infection *Reyataz oral powder approved for use in pediatric patients at least 3 months and between 10 kg to less than 25 kg; capsule previously approved in 6 years and older* Not recommended in pediatric patients less than 3 months because of the risk of kernicterus* Reyataz oral powder contains phenylalanine which can be harmful to patients with phenylketonuria * Adverse reactions were similar to those observed in adults* Oral powder must be mixed with food or beverage for administration and ritonavir must be given immediately afterwards * Information on mixing oral powder with food such as appleasauce or yogurt or milk, water or infant formula * Information on dosing in patients at least 3 months and weighing between 10 to less than 25kg, adverse reactions, laboratory abnormalities, PK parameters, and clinical trials* New dosage form Antiviral
05/27/2014 Aloxi palonosetron hydrochloride Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) and postoperative nausea and vomiting (PONV) Chemotherapy-Induced Nausea and Vomiting *Approved for prevention of acute CINV in 1 month - < 17 years* Safety and effectiveness in neonates less than 1 month of age have not been established* Pediatric patients require a higher palonosetron dose than adults (20 mcg/kg with max of 1.5 mg x 1 vs 0.25 mg x 1 *Adverse reactions were similar to those observed in adults *Information on dosing, PK parameters, clinical trial, adverse reactions Postoperative Nausea and Vomiting Studies *Safety and efficacy have not been established in pediatric patients for PONV *Adverse reactions were similar to those observed in adults* Information on dosing, clinical trials Antiemetic
04/28/2014 Delzicol mesalamine Treatment of mildly to-moderately active ulcerative colitis *Approved for use in pediatric patients 12 years and older based on clinical trials conducted with mesalamine 400 mg delayed release tablets which is approved in 5-17 years* Delzicol is bioequivalent to the mesalamine delayed-release tablets *There is no age appropriate Delzicol formulation available for patients less than 12 years *Safety and effectiveness of Delzicol in the maintenance of remission of ulcerative colitis in pediatric patients have not been established *Information on dosing* New dosage form Anti-Inflammatory
04/25/2014 Asmanex HFA mometasone furoate Maintenance treatment of asthma as prophylactic therapy *Approved for use in adults and pediatric patients 12 years and older *Safety and efficacy hav not been established in children less than 12 years *The growth of pediatric patients receiving orally inhaled corticosteroids should be monitored routinely *To minimize the systemic effects of orally inhaled corticosteroids each patient should be titrated to his/her lowest effective dose *Information on dosing, adverse reactions, and clinical trials *New dosage form Antiasthmatic
04/23/2014 Kuvan sapropterin dihydrochloride Treatment to reduce blood phenylalanine (Phe) levels in patients with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin- (BH4-) responsive Phenylketonuria (PKU) * Expanded indication to include 1 month to 4 years; previously approved for use in 4 years and older * Safety and effectiveness have not been established in neonates * Adversereactions observed in pediatric patients 1 month – 6 years were similar to adults except for an increased incidence of low Phe levels. 25% (16/65) experienced low Phe for age * Information on adding crushed tablet or powder for oral solution to small amounts of soft food such as apple sauce* Information on dosing, adverse reactions, PK parameters, and clinical trials
04/11/2014 GRASTEK Timothy Grass Pollen Allergen Extract* Treatment of grass pollen-induced allergic rhinitis or conjunctivitis See Package Insert for new information on biologics Immunologic agent
04/01/2014 ORALAIR Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract* Treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis See Package Insert for new information on biologics Antiallergy
03/28/2014 Topamax topiramate Prophylaxis of migraine headache * Approved for use in pediatric patients 12 years and older * Safety and effectiveness in pediatric patients less than12 years have not been established for the prophylaxis treatment of migraine headache * In the adolescent migraine trials (12 to 17 years), the most commonly observed adverse reactions were: paresthesia, upper respiratory tract infection, anorexia, and abdominal pain * The most common cognitive adverse reaction in pooled double-blind studies in adolescent patients 12 to 17 years was difficulty with concentration/attention * Markedly abnormally low serum bicarbonate values indicative of metabolic acidosis were reported in topiramate-treated adolescent migraine patients * In topiramate-treated patients 12 to 17 years compared to placebo-treated patients, abnormally increased results were more frequent for creatinine, BUN, uric acid, chloride, ammonia, total protein, and platelets. Abnormally decreased results were observed with topiramate vs placebo treatment for phosphorus and bicarbonate * Notable changes (increases and decreases) from baseline in systolic blood pressure, diastolic blood pressure, and pulse were observed more commonly in adolescents treated with topiramate compared to adolescents treated with placebo * Information on dosing, adverse reactions, laboratory abnormalities, and clinical trials * Postmarketing study Antimigraine
03/21/2014 Xolair omalizumab Chronic Idiopathic Urticaria (CIU) * Approved for the treatment of CIU in adults and pediatric patients 12 years and older who remain symptomatic despite H1 antihistamine treatment * Clinical studies with Xolair have not been conducted in CIU patients less than 12 years. Considering the risk of anaphylaxis and malignancy seen in Xolair-treated patients 12 years and older, the use of Xolair in patients less than 12 years is not recommended * Dosing in CIU is not based on serum IgE level or body weight * Adverse reactions in adolescents and adults were similar and include miscellaneous infections, arthralgias, headache, nausea, and cough * Information on adverse reactions, dosing, and clinical trials in adults and pediatric patients 12 years and older Antiasthmatic; antiallergy
03/20/2014 Baraclude entecavir Treatment of chronic hepatitis B virus (HBV) infection * Approved for use in pediatric patients 2 years and older * Safety and effectiveness have not been established in pediatric patients less than 2 years. Use in this age group has not been evaluated because treatment of HBV in this age group is rarely required * There are limited data available on the use of Baraclude in lamivudine-experienced pediatric patients * Adverse reactions in clinical trials were similar to those observed in adults * Information on dosing in pediatric patients 2 years and weighing at least 10 kg, adverse reactions, PK parameters and clinical trials * New dosage form Antiviral
03/07/2014 Pancreaze pancrelipase Postmarketing study *New dosage strength of 2,600 USP lipase units to allow for dosing in infants up to 12 months*Postmarketing study* New dosage form Pancreatic enzyme
03/06/2014 Revatio sildenafil Treatment of pulmonary arterial hypertension (PAH) *Labeling updated to include information on results of an open-label pediatric safety extension study* During the study, there were 42 deaths with 37 of these deaths reported prior to a decision to titrate patients to a lower dosage because of a finding of increased mortality. An increase in mortality was observed with increasing doses *Causes of death in the extension study were typical of patients with PAH Peripheral vasodilator
01/22/2014 Xerese acyclovir/ hydrocortisone Treatment of recurrent herpes labialis * Expanded indication to include 6 years to less than 12 years; previously approved for use in 12 years and older *Safety and effectiveness in pediatric patients less than 6 years of age have not been established *Adverse reactions similar to those observed in adults* Information on dose, and clinical trial Antiviral, topical
01/17/2014 Aleve PM naproxen sodium 220 mg and diphenhydramine hydrochloride 25 mg Relief of occasional sleeplessness when associated with minor aches and pains and helps fall asleep and stay asleep *Approved for use in adults and children 12 years and older * Not approved for use in children less than 12 years* New drug anti-inflammatory+sleep aid
12/20/2013 Isentress raltegravir HIV-1 infection *Packet for oral suspension: Approved for use in infants 4 weeks and older, weighing at least 3 kg to < 20 kg. Chewable tablet previously approved down to 2 years* Safety and dosing information have not been established in infants less than 4 weeks *Adverse reactions similar to those observed in adults* Information on dosing,clinical trial and PK parameters*Information on preparation of a suspension*New dosage form Antiviral
12/10/2013 Xeloda capecitabine Newly diagnosed brainstem gliomas and high grade gliomas *The safety and effectiveness in pediatric patients have not been established *No clinical benefit was demonstrated in 2 single arm trials in pediatric patients* The adverse reaction (AR) profile was consistent with the known AR profile in adults, with the exception of laboratory abnormalities which occurred more commonly in pediatric patients* Information on dosing, adverse reactions, and clinical trials Antineoplastic
11/25/2013 Noxafil posaconazole Prophylaxis of invasive Aspergillus and Candida infections in high risk patients *Safety and effectiveness have been established in pediatric patients 13 - 17 years. Use is supported by evidence from adequate and well-controlled studies in adults. PK and safety in pediatric patients 13 - 17 years were also assessed and are similar to adults.* Safety and effectiveness in pediatric patients less than 13 years have not been established* Information on dosing, PK, and clinical trials Antifungal
11/22/2013 Nitropress sodium nitroprusside Immediate reduction of blood pressure in hypertensive crisis *Efficacy in the pediatric population was established based on adult trials and supported by a dose-ranging trial and an open label trial that achieved adequate mean arterial pressure control in pediatric patients *No novel safety issues were found in these two studies. *Information on dosing, PK parameters and clinical trials Antihypertensive
10/26/2013 Sabril vigabatrin Refractory complex partial seizures (rCPS) *Approved as adjunctive therapy for pediatric patients 10 years and older with rCPS for whom the potential benefits outweigh the risk of vision loss. Sabril is not a first line agent for rCPS * Safety and effectiveness for pediatric patients less than 10 years with refractory rCPS have not been established *Pooled data from 3 controlled trials in pediatric patients demonstrated that 6% (10/165) of Sabril patients experienced somnolence compared to 5% (5/104) of placebo patients. In those same studies, 10% (17/165) of Sabril patients experienced fatigue compared to 7% (7/104) of placebo patients; 47% (77/163) of Sabril patients versus 19% (19/102) of placebo patients gained greater than or equal to 7% of baseline body weight *Adverse reactions (ARs) in the pediatric population were similar to those reported in adults. Overall, ARs in pediatric patients 10-16 years included increased weight, upper respiratory tract infection, tremor, fatigue, aggression and diplopia *Information on weight based dosing, dosing in renal impairment, safety information and clinical trials Anticonvulsant
10/24/2013 Ecoza econazole nitrate Treatment of interdigital tinea pedis *Approved for use in 12 years and older * Safety findings for patients 12 - 17 years were similar to those in adults * Information on clinical trials and PK* New dosage form Antifungal, topical
10/18/2013 Asacol HD mesalamine Postmarketing study using Asacol *Safety and effectiveness of Asacol HD in pediatric patients have not been established *Since studies were performed in Asacol rather than Asocol HD, information added to labeling referring reader to prescribing information for other approved mesalamine products for the safety and effectiveness of these products in pediatric patients Anti-inflammatory
10/18/2013 Asacol mesalamine Treatment of mildly to moderately active ulcerative colitis *Safety and effectiveness in pediatric patients 5 - 17 years have been established over a 6-week period. Use in this age group is supported by evidence from studies in adults and 1 study in pediatric patients*Safety and effectiveness in pediatric patients below 5 years have not been established*Safety and effectiveness for the maintenance of remission of ulcerative colitis in pediatric patients have not been established*Adverse reactions in the pediatric population were similar to those reported in adults*Information on dose, adverse reactions, PK and clinical trials*Postmarketing study Anti-inflammatory
10/15/2013 Novoeight Antihemophilic Factor (Recombinant)* For adults, adolescents, and children with hemophilia A for (1) the control and prevention of bleeding episodes, (2) perioperative management, and (3) routine prophylaxis to prevent or reduce the frequency of bleeding episodes. See Package Insert for new information on biologics
08/30/2013 Astepro Nasal Spray azelastine Treatment of perennial and seasonal allergic rhinitis *Expanded the indication to pediatric patients down to 6 years; previously approved in pediatric patients 12 years and older *Safety and effectiveness in pediatric patients < 6 years have not been established *Information on dosing, clinical trial, and adverse reactions *Postmarketing study" Anti-inflammatory, topical
08/21/2013 Lysteda tranexamic acid Treatment of cyclic heavy menstrual bleeding *Indicated for women of reproductive age. It is not intended for use in premenarcheal girls *Information on PK study*Postmarketing study
08/16/2013 FluLaval Influenza Virus Vaccine* Active immunization for the prevention of disease caused by influenza A subtype viruses and type B virus contained in the vaccine See Package Insert for new information on biologics Preventive Vaccine
08/16/2013 FluLaval Quadrivalent Influenza Virus Vaccine* Active immunization for the prevention of disease caused by influenza A subtype viruses and type B viruses contained in the vaccine See Package Insert for new information on biologics Preventive Vaccine
08/12/2013 Tivicay dolutegravir Treatment of HIV-1 infection "*Indicated in combination with other antiretroviral agents in adults and children aged 12 years and older and weighing at least 40 kg *Not recommended in pediatric patients <12 years or weighing < 40 kg *Safety and efficacy have not been established in pediatric patients who are integrase strand transfer ibitor (INSTI)-experienced with documented or clinically suspected resistance to other INSTIs (raltegravir, elvitegravir) *The safety, virologic, and unologic were evaluated in 23 treatment-experienced, INSTI-naïve, HIV-1 infected patients aged 12 - < 18 years in an open-label, multicenter, dose-finding clinical trial *Adverse reactions were similar to those observed in adults * Information on dosing, clinical trial, and PK *New drug Antiviral
08/01/2013 MENVEO Meningococcal (Groups A, C, Y, and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine* Active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135 See Package Insert for new information on biologics Preventive Vaccine
07/26/2013 Symbyax olanzapine and fluoxetine hydrochloride Treatment of depressive episodes associated with bipolar I disorder "*Expanded the indication from adults to pediatric patient 10-17 years *Safety and efficacy for treatment resistant depression in patients < 18 years have not been established *Symbyax is not approved for any indication in patients < 10 years *In a placebo-controlled clinical trial in patients 10 to 17 years, somnolence-related adverse events were commonly reported with drug treatment occurring in 23.5% of drug-treated patients compared with 2.4% of placebo-treated patients *The types of adverse reactions observed with olanzapine and fluoxetine hydrochloride in children and adolescents were similar to adult but the magnitude and frequency of some changes were greater in children and adolescents than adults. These included increases in lipids, hepatic enzymes, and prolactin, and increases in the QT interval. The frequency of weight gain greater than or equal to 7%, and the magnitude and frequency of increases in lipids, hepatic analytes, and prolactin in children and adolescents treated with olanzapine and fluoxetine hydrochloride were similar to those observed in adolescents treated with olanzapine monotherapy *Overall, 14.1% of the 170 patients in the olanzapine and fluoxetine hydrochloride group discontinued due to adverse reactions compared with 5.9% of the 85 patients for placebo. Adverse reactions leading to discontinuation associated with the use of olanzapine and fluoxetine hydrochloride were weight increased (2.9%), suicidal ideation (1.8%), bipolar disorder (1.2%), and somnolence (1.2%) versus placebo patients which had 0% incidence of weight increased, bipolar disorder, and somnolence, and a 1.2% incidence of suicidal ideation *Information on dosing, clinical trial, and adverse reactions Antidepressant
06/21/2013 Mycamine micafungin sodium Treatment of patients with candidemia, acute disseminated candidiasis, Candida peritonitis and abscesses; treatment of patients with esophageal candidiasis; prophylaxis of Candida infections in patients undergoing hematopoietic stem cell transplantation *Safety and effectiveness in pediatric patients 4 months and older have been demonstrated based on the evidence from adequate and well-controlled studies in adult and pediatric patients and additional pediatric pharmacokinetic and safety data*Safety and effectiveness in pediatric patients < 4 months have not been established*In all pediatric studies with Mycamine, 439/479 (92%) patients experienced at least one treatment-emergent adverse reaction. Gastrointestinal symptoms including vomiting, diarrhea, nausea, abdominal pain, and abdominal distension occurred in 285 pediatric patients (60%)*Information on population PK, dosing, adverse reactions, and clinical trials *Postmarketing study Antiviral
06/17/2013 Precedex dexmedetomidine hydrochloride Loading and maintenance infusion for sedation in intubated and mechanically ventilated pediatric patients *Safety and efficacy have not been established for procedural or ICU sedation in pediatric patients *One assessor-blinded trial in pediatric patients and two open label studies in neonates were conducted to assess efficacy for ICU sedation. These studies did not meet their primary efficacy endpoints and the safety data submitted were insufficient to fully characterize the safety profile of dexmedetomidine for this patient population *Use for procedural sedation in pediatric patients has not been evaluated Sedative
06/07/2013 Fluzone Quadrivalent Influenza Virus Vaccine* Active immunization for the prevention of influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine. See Package Insert for new information on biologics Preventive Vaccine
05/31/2013 Bloxiverz neostigmine methylsulfate Reversal of the effects of non-depolarizing neuromuscular-blocking agents after surgery "*Approved for use in pediatric patients of all ages *The evidence for efficacy of neostigmine is derived from the published literature * Recovery of neuromuscular activity occurs more rapidly with smaller doses of cholinesterase inhibitors in infants and children than in adults. However, infants and small children may be at greater risk of complications from incomplete reversal of neuromuscular blockade due to decreased respiratory reserve. The risks associated with incomplete reversal outweigh any risk from giving higher doses of neostigmine *Since the blood pressure in pediatric patients, particularly infants and neonates is sensitive to changes in heart rate, the effects of an anticholinergic agent (e.g., atropine) should be observed prior to administration of neostigmine to lessen the probability of bradycardia and hypotension *Information on dose, and pk *New drug Neuromuscular blockade reversal
05/30/2013 Kepivance palifermin Acute leukemias undergoing myeloablative therapy and allogeneic hematopoietic stem cell transplant * Use in pediatric patients ages 1 - 16 years is supported by evidence from adequate and well-controlled studies in adults and a phase 1 study that included 27 pediatric patients with acute leukemia undergoing hematopoietic stem cell transplant * Postmarketing study Immunologic agent
05/17/2013 Ixiaro Japanese Encephalitis Vaccine, Inactivated, Adsorbed* Prevention of disease caused by Japanese encephalitis virus See Package Insert for new information on biologics Preventive Vaccine
05/02/2013 Sustiva efavirenz Treatment of HIV-1 infection * Labeling updated with dosing recommendations for pediatric patients 3 months - 3 years and weighing at least 3.5 kg * Use in pediatric patients < 3 months OR less than 3.5 kg body weight is not recommended because the safety, pharmacokinetics, and antiviral activity have not been evaluated and there is a risk of developing HIV resistance if efavirenz is underdosed.* Information on population PK, safety, virologic, and immunologic response from 3 open-label clinical trials in patients 3 months - 21 years.* Postmarketing study Antiviral
04/30/2013 Seroquel and Seroquel XR quetiapine Bipolar depression * Efficacy was not established in an 8-week placebo-controlled monotherapy trial of Seroquel XR in children and adolescents 10-17 years with bipolar depression.* In the same study patients treated with Seroquel XR exhibited metabolic changes, weight gain, and increases in blood pressure and heart rate.* The most commonly observed adverse reactions were dizziness 7%, diarrhea 5%, fatigue 5% and nausea 5% * Information on adverse reactions, clinical tria * Postmarketing study Antipsychotic
04/26/2013 Vyvanse Capsules lisdexamfetamine Maintenance treatment of ADHD *Approved for the maintenance treatment of ADHD in pediatric patients 6-17 years * Information on one short term efficacy trial and one maintenance trial in pediatric patients 6-17 years * New indication CNS Stimulant
04/24/2013 Prezista darunavir Treatment of HIV-1 infection * Revised labeling to include pharmacokinetic, safety, tolerability, and virologic response data from a 48 week study for HIV-1 treatment experienced pediatric patients 3 to < 6 years * Additional information on adverse reactions * Postmarketing study Antiviral
04/11/2013 Doryx doxycycline hyclate Uncomplicated urogenital Chlamydia trachomatis infection * New 200-mg strength tablet * New alternative dosage regimen for adults and children at least 8 years and weighing 45 kg based on studies in adults * New dosage form, new dosage regimen Antibiotic
03/29/2013 Salonpas Pain Relief methyl salicylate 10% and l-menthol 3% Temporary relief of mild to moderate aches and pains of muscles and joints associated with arthritis, simple backache, strains, bruises and sprains *Children under 18 years of age: do not use; this product has not been shown to work in children *Postmarketing study Analgesic, topical
03/28/2013 Karbinal ER carbinoxamine maleate Relief of seasonal and perennial allergic rhinitis, vasomotor rhinitis, allergic conjunctivitis due to inhalant allergens and foods, mild uncomplicated allergic skin manifestations of urticaria and angioedema, dermatographism, as therapy for anaphylactic reactions adjunctive to epinephrine and other standard measures after the acute manifestations have been controlled, and amelioration of the severity of allergic reactions to blood or plasma *Approved for use in 2-17 years *Efficacy and safety is based on demonstration of bioequivalence to the immediate release product * Deaths have been reported in children younger than 2 years who were taking carbinoxamine containing drug products. Therefore, Karbinal ER is contraindicated in children younger than 2 years of age and in nursing mothers. *Carbinoxamine may diminish mental alertness or produce sedation in children *Paradoxical reactions with excitation are more likely in younger children *Karbinal ER must be measured with an accurate milliliter measuring device *Information on safety, dosing, and adverse reactions •New dosage form Antihistamine
03/28/2013 Quartette levonorgestrel/ethinyl estradiol and ethinyl estradiol Prevention of pregnancy * Safety and efficacy have been established in women of reproductive age. Efficacy is expected to be the same for postpubertal adolescents less than 18 years and for users 18 years and older. *Use before menarche is not indicated Contraceptive
03/26/2013 Aciphex rabeprazole Gastroesophageal reflux * Expanded the indication to pediatric patients down to 1 year; previously approved in pediatric patients 12 years and older * Studies do not support the use in pediatric patients < 1 year * Use in neonates is strongly discouraged based on the risk of prolonged acid suppression and lack of demonstrated safety and effectiveness in neonates * Adverse reactions were similar to those observed in adults and adolescents * Information on clinical studies, dosing, population PK in neonates, and adverse reaction Antiulcerative
03/22/2013 Durezol difluprednate Treatment of post-operative inflammation following cataract surgery *Expanded the indication from adults to pediatric patients*Difluprednate compared to prednisolone acetate ophthalmic was evaluated in a 3-month, multicenter, double-masked trial in 79 pediatric patients 0 to 3 years for the treatment of inflammation following cataract surgery*A similar safety profile was observed in pediatric and adult patients Anti-inflammatory, topical
03/21/2013 Phenylephrine Hydrochloride phenylephrine hydrochloride Dilation of the pupil *The 2.5% solution are approved for use in pediatric patients of all ages*The 10% solution is approved for patients 1 year and older and contraindicated in pediatric patients < 1 year of age due to the increased risk of systemic toxicity*New Drug Ophthalmologic
03/20/2013 Dotarem gadoterate meglumine Contrast agent for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues to detect and visualize areas with disruption of the blood brain barrier and/or abnormal vascularity *Safety and efficacy have been established in pediatric patients from 2 to 17 years*Safety and efficacy have not been established in pediatric patients < 2 years*Information on clinical trial, dosing, adverse reactions*New Drug Medical imaging
03/15/2013 Recothrom Thrombin, topical (Recombinant) * Aid hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques (such as suture, ligature, or cautery) is ineffective or impractical See Package Insert for new information on biologics Topical thrombin
02/27/2013 Intelence etravirine Postmarketing study *Information on 48 week safety*The safety profile for patients who completed 48 weeks of treatment was similar to the safety profile for patients who completed 24 weeks of treatment*Postmarketing study Antiviral
02/06/2013 Zylet loteprednol etabonate and tobramycin Treatment of blepharoconjunctivitis "" Efficacy was not demonstrated in a study of pediatric patients 0-6 years" Antibiotic, topical
02/01/2013 Epiduo adapalene and benzoyl peroxide Treatment of acne vulgaris *Expanded age range down to 9 years; previously approved in pediatric patients 12 years and older*Safety and effectiveness in pediatric patients < 9 years have not been established*Adverse reactions were similar to those observed in adults*Information on clinical trial*Postmarketing study Antiacne, topical
02/01/2013 Prezista darunavir Treatment of HIV-1 infection *Revised labeling to include once daily dosing in treatment naïve and treatment experienced HIV-1 infected pediatric patients 3 to < 18 years and weighing at least 10 kg * Postmarketing study Antiviral
01/25/2013 Prevnar 13 Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein) * Active immunization for the prevention of invasive pneumococcal disease caused by S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F and active immunization for the prevention of otitis media caused by S. pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F See Package Insert for new information on biologics Preventive Vaccine
01/23/2013 Exjade deferasirox Treatment of chronic iron overload in patients with non-transfusion dependent thalassemia *Approved for use in 10 years and older for NTDT *Safety and effectiveness have not been established in pediatric patients less than 10 years * Information on dosing, adverse reactions in adults and pediatric patients, and clinical trials * New indication Iron chelator
01/09/2013 Skyla levonorgestrel-releasing intrauterine system Prevention of pregnancy for up to 3 years *Safety and efficacy have been established in women of reproductive age*Efficacy is expected to be the same for postpubertal females under the age of 18 years as for users 18 years and older*Use of this product before menarche is not indicated*New drug Contraceptive
12/21/2012 Altabax Ointment retapamulin Treatment of impetigo *Use of retapamulin is not indicated in pediatric patients < 9 months* In an open-label clinical study of topical treatment in pediatric patients 2 to 24 months, systemic exposure of retapamulin was higher compared with patients 2 to 17 years. A higher proportion of pediatric patients 2 to 9 months of age had measurable concentrations of retapamulin compared with patients 9 to 24 months of age. The highest levels were seen in patients 2 to 6 months of age*Postmarketing study Antibiotic, topical
12/19/2012 Advair HFA fluticasone/ salmeterol Treatment of asthma *Safety and effectiveness in children < 12 years have not been established.* Information on clinical trials, adverse reactions, and pharmacokinetics/ pharmacodynamics, * Postmarketing study Antiasthmatic
12/14/2012 Fluarix Quadrivalent Influenza Virus Vaccine* Include a quadrivalent influenza virus vaccine formulation (Fluarix® Quadrivalent) See Package Insert for new information on biologics Vaccine
11/30/2012 Invirase saquinavir Treatment of HIV infection in combination with ritonavir *The safety and activity of saquinavir have been evaluated in 68 pediatric patients 4 months -< 16 years treated with Invirase boosted with either ritonavir or with lopinavir/ritonavir in 2 clinical trials. * Steady state saquinavir exposures observed in pediatric trials were substantially higher than historical data in adults where dose- and exposure-dependent QTc and PR prolongation were observed. Pediatric dose recommendations that are both reliably effective and below thresholds of concern with respect to QT and PR prolongation could not be determined. * Information on clinical studies, and pharmacokinetics Antiviral
11/08/2012 VIRAMUNE XR nevirapine Treatment of HIV-1 infection * Approved for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in children 6 - < 18 years. Use in pediatric patients 6 - < 18 years is based on pharmacokinetic, safety, and antiviral activity data from an open-label trial and supported by previous demonstration of efficacy in adults. * Not recommended for children < 6 years since clinical trial did not provide sufficient pharmacokinetic data for children 3 - < 6 years to support the use in this age group. Furthermore, not recommended for children < 3 years because they are not able to swallow tablets. * Viramune XR tablets must be swallowed whole and must not be chewed, crushed, or divided. * Children should be assessed for their ability to swallow tablets before prescribing * No recommendations can be made regarding substitution of four VIRAMUNE XR 100 mg tablets for one VIRAMUNE XR 400 mg tablet * Pediatric patients may be dosed using Viramune XR 400 mg or 100 mg tablets. Viramune XR is dosed based on a patients body surface area (BSA). All pediatric patients must initiate therapy with immediate-release Viramune at a dose not to exceed 200 mg per day, administered once daily for the first 14 days because it has been demonstrated to reduce the frequency of rash. This lead-in period is not required if the patient is already on a regimen of twice daily immediate-release formulation * Adverse reactions were similar to those observed in adults. In pediatric patients the incidence of Grade 2 or higher drug-related rash was 1%Information on recommended dosing based on BSA, pharmacokinetics, adverse reactions, and clinical trial * Postmarketing study Antiviral
10/22/2012 Fycompa perampanel Treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy *The safety and efficacy was established by 3 double blind, placebo-controlled studies which included 72 pediatric patients 12 - 16 years old exposed to perampanel *The safety and effectiveness in pediatric patients <12 years old have not been established *Most common adverse reactions in adult and pediatric patients include dizziness, somnolence, fatigue, irritability, falls, nausea, weight gain, vertigo, ataxia, gait disturbance, and balance disorder *Information on clinical trials, dosing, adverse reactions, and pharmacokinetics * New drug Anticonvulsant
10/19/2012 Oxtellar XR oxcarbazepine Adjunctive therapy of partial seizures *Safety and effectiveness in pediatric patients ages 6 - 16 years with partial onset seizures is supported by an adequate and well-controlled short term safety and efficacy study in adults that included pharmacokinetic sampling, a pharmacokinetic study in pediatric patients ages 4 - 16 years, and safety and efficacy studies with the immediate-release formulation in adults and pediatric patients * Oxtellar XR is not approved for pediatric patients < 6 years because the size of the tablets are inappropriate for younger children, and has not been studied in patients < 4 years * Information on dosing, adverse reactions, and pharmacokinetics * New dosage form Anticonvulsant
10/18/2012 Cymbalta duloxetine hydrochloride Treatment for Major Depressive Disorder (MDD) *Efficacy was not demonstrated in two 10-week, placebo-controlled trials with 800 pediatric patients with MDD, age 7-17 *Duloxetine has not been studied in pediatric patients less than 7 years *Decreased appetite and weight loss have been observed in association with the use of SSRIs and SNRIs. Pediatric patients treated with duloxetine in MDD clinical trials experienced a 0.2 kg mean decrease in weight at 10-weeks, compared with a mean weight gain of approximately 0.6 kg in placebo-treated patients. The proportion of patients who experienced a clinically significant decrease in weight (>3.5%) was greater in the duloxetine group than in the placebo group (11% and 6%, respectively). Subsequently, over the six-month uncontrolled extension period, most duloxetine treated patients trended toward recovery to their expected baseline weight. Perform regular monitoring of weight and growth in children and adolescents treated with an SNRI such as duloxetine *In the 2 pediatric MDD studies, the safety findings were consistent with the known safety and tolerability profile for duloxetine *Information on clinical trial, pharmacokinetics, and juvenile animal study Antidepressant
10/12/2012 Bethkis tobramycin Management of cystic fibrosis patients with P. aeruginosa *Safety and efficacy have been established in adults and children 6 years and older *Safety and efficacy have not been studied in pediatric patients less than 6 years *Use caution in patients with known or suspected auditory or vestibular dysfunction or renal dysfunction. Bronchospasm can occur with inhalation of tobramycin *Information on dose, adverse reactions, and clinical trials *New drug Antibiotic, topical
10/10/2012 Lunesta eszopiclone Attention-Deficit Hyperactivity Disorder associated insomnia *Safety and effectiveness have not been established in pediatric patients*Lunesta failed to demonstrate efficacy in a 12-week controlled study of 483 pediatric patients 6-17 years with insomnia associated with ADHD *Psychiatric and nervous system disorders comprised the most frequent treatment emergent adverse reactions observed with Lunesta versus placebo and included dysgeusia (9% vs. 1%), dizziness (6% vs. 2%), hallucinations (2% vs. 0%) and suicidal ideation (0.3% vs. 0%) * Information on dose, adverse reactions clinical trial and juvenile animal studies Hypnotic
09/27/2012 QUILLIVANT XR methylphenidate hydrochloride Treatment of Attention Deficit Hyperactivity Disorder *Safety and effectiveness have been established in pediatric patients ages 6 - 17 years *Use in pediatric patients 6 - 12 years of age is supported by adequate and well-controlled studies. Use in 12 - 17 year olds is supported by the adequate and well-controlled studies of Quillivant XR in younger pediatric patients and additional pharmacokinetic data in adolescents, with safety information from other methylphenidate products *The long-term efficacy of methylphenidate in pediatric patients has not been established *Safety and efficacy in pediatric patients below the age of 6 years have not been established *Growth should be monitored during treatment with stimulants, including Quillivant XR. Children who are not growing or gaining weight as expected may need to have their treatment interrupted *Information on adverse reactions, pharmacokinetics and clinical tria l*New dosage form CNS Stimulant
09/21/2012 Venofer iron sucrose Treatment of iron deficiency anemia in patients with chronic kidney disease (CKD) *Expanded the indication from adults to pediatric patients 2 years and older* Safety and effectiveness for iron maintenance treatment in pediatric patients 2 years of age and older with dialysis-dependent or non-dialysis-dependent CKD receiving erythropoietin therapy were studied *Safety and effectiveness for iron replacement treatment in pediatric patients with dialysis-dependent or non-dialysis-dependent CKD have not been established *Venofer has not been studied in patients < 2 years *The mean Cmax and AUC values were 1.42- and 1.67-fold higher than dose adjusted adult Cmax and AUC values *The most common treatment-emergent adverse reactions were headache (6%), respiratory tract viral infection (4%), peritonitis (4%), vomiting (4%), pyrexia (4%), dizziness (4%), cough (4%), renal transplant (4%), nausea (3%), arteriovenous fistula thrombosis (2%), hypotension (2%), and hypertension (2.1%) *Information on dosing, adverse reactions, pharmacokinetics, and clinical trial * Postmarketing study Iron Replacement
08/30/2012 Revatio sildenafil Treatment of pulmonary arterial hypertension *Use of Revatio, particularly chronic use, is not recommended in children *In a double-blind, placebo-controlled, dose-ranging study, 234 pediatric patients with PAH 1 - 17 years were randomized based on body weight to three dose levels of Revatio, or placebo, for 16 weeks. No patients died during the 16-week study *In a long-term trial, an increase in mortality with increasing dose was observed. Deaths were first observed after about 1 year and causes of death were typical of patients with PAH * Information on safety, and clinical trials Peripheral Vasodilator
08/29/2012 Afinitor Disperz everolimus Treatment of subependymal giant cell astrocytoma (SEGA) in patients with tuberous sclerosis complex (TSC) *Approved for patients 1 year and older with TSC for the treatment of SEGA that requires therapeutic intervention but cannot be curatively resected *The safety and effectiveness of Afinitor Tablets and Afinitor Disperz have not been established in pediatric patients with renal angiomyolipoma with TSC in the absence of SEGA * The effectiveness in pediatric patients with SEGA was demonstrated in two clinical trial * The long term effects of Afinitor on growth and pubertal development are unknown *Information on starting dose, therapeutic drug monitoring, clinical trial, and adverse reactions *New formulation Antineoplastic
08/16/2012 Viread tenofovir disoproxil fumarate Treatment of chronic hepatitis B *Expanded the indication from adults to pediatric patients 12 - < 18 years of age, weighing at least 35k*Safety and efficacy in pediatric patients with chronic hepatitis B < 12 years old or weighing < 35 kg have not been established *In a clinical trial in pediatric patients 12 - <18 years, the mean rate of bone mineral density gain was less in Viread-treated patients compared to placebo* Information on dosing, adverse reactions, and clinical trial *Postmarketing study Antiviral
08/02/2012 Risperdal risperidone Postmarketing study * Information on postmarketing clinical study of a lower than recommended dose for irritability associated with autistic patients in patients 5 to 17 years * Postmarketing study Antipsychotic
06/26/2012 Treanda bendamustine hydrochloride Relapsed or refractory acute leukemia *Effectiveness in pediatric patients has not been established * Treanda was evaluated in a Phase 1/2 trial in pediatric patients with leukemia *The safety profile in pediatric patients was consistent with that seen in adults, and no new safety signals were identified *Information on dosing, clinical trials and PK parameters Antineoplastic
06/14/2012 MENHIBRIX Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine* Active immunization to prevent invasive disease caused by Neisseria meningitidis serogroups C and Y and Haemophilus influenzae type b See Package Insert for new information on biologics Preventive Vaccine
05/30/2012 Torisel temsirolimus Advanced recurrent/refractory solid tumors * Effectiveness in pediatric patients has not been established * Torisel was studied in 59 patients 1 - 17 years and 12 patients 18 to 21 years in a phase 1-2 safety and exploratory pharmacodynamic study * Adverse reactions were similar to those observedd in adults * Information on dosing, clinical trials and PK parameters Antineoplastic
05/17/2012 Pertzye pancrelipase Treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions * Safety and efficacy assessed in a clinical trial that included 10 patients 8 - 17 years *Safety and efficacy of pancreatic enzyme products with different formulations of the same active ingredient for use in children have been described in medical literature and through clinical experience * Use in children is limited by the available capsule dosage strengths and their ability to provide the recommended dose based on age and weight. Attempting to divide the capsule contents in small fractions to deliver small doses of lipase is not recommended *High doses of pancreatic enzyme products have been associated with fibrosing colonopathy in children <12 years of age *Capsule should be swallowed whole. Capsule and contents should not be crushed or chewed *For patients unable to swallow intact capsules, the contents may be sprinkled on soft acidic food such as applesauce and swallowed immediately * Not interchangeable with other pancrelipase products *New drug Pancreatic enzyme
05/12/2012 Voluven 6% Hydroxyethyl Starch 130/0.4 In 0.9% Sodium Chloride Injection* Plasma volume substitute for treatment and prophylaxis of hypovolemia See Package Insert for new information on biologics Coagulant
05/01/2012 Dymista azelastine hydrochloride and fluticasone proprionate Relief of symptoms of seasonal allergic rhinitis *Safety and effectiveness have been established in 3 clinical trials in patients 12 years and older *Safety and effectiveness in pediatric patients < 12 years have not been established *Intranasal corticosteroids may cause a reduction in growth velocity in pediatric patients. The growth of pediatric patients receiving intranasal corticosteroids, including Dymista, should be monitored routinely *Information on dosing, adverse reactions, and clinical trials *New drug Antiasthmatic;antiallergy
04/27/2012 Lexiva fosamprenavir Treatment of HIV-1 infection * Expanded indication to include pediatric patients at least 4 weeks - <2 years; previously approved for use in 2  18 years *The PK, safety, tolerability, and efficacy in pediatric patients < 4 weeks have not been established *Dosing of Lexiva plus ritonavir is not recommended for protease inhibitor-experienced pediatric patients <6 months of age; data do not support twice-daily dosing of Lexiva without ritonavir in pediatric patients <2 years *Weight-adjusted apparent clearance was higher in children < 4 years, suggesting that younger children require higher mg per kg dosing of Lexiva *Vomiting and neutropenia were more frequent in pediatrics than in adults. Other adverse reactions were similar to adults * Information on dosing, clinical trials, PK and adverse reactions *New dosage regimen for patients at least 4 weeks - < 6 years; Postmarketing study Antiviral
04/27/2012 Levaquin levofloxacin Treatment and prophylaxis of plague due to Yersinia pestis * Approved for the treatment and prophylaxis of plague due to Yersinia pestis in patients 6 months and older *Efficacy studies could not be conducted in humans with pneumonic plague for ethical and feasibility reasons. Approval of this indication was based on an efficacy study conducted in animals *Safety and effectiveness in pediatric patients < 6 months have not been established *Information on animal study *New indication Antibiotic
03/26/2012 Singulair Oral Granules, Tablets, and Chewable Tablets montelukast Prevention of exercise-induced bronchoconstriction * Expanded indication to include pediatric patients from 6 - 14 years; previously approved for use in 15 years and older *Efficacy for prevention of EIB in patients < 6 years of age has not been established * Information on clinical trial, and dosing * Postmarketing study Antiasthmatic; antiallergy
03/26/2012 Intelence etravirine Treatment of HIV-1 infection in treatment-experienced patients in combination with other antiretroviral agents * Expanded the indication from adults to pediatric patients 6 years and older * Safety and efficacy have not been established in children < 6 years or in treatment naive adult or pediatric patients *Adverse reactions were similar to those observed in adults except for rash which was observed more frequently in pediatric patients (15%) compared to adults (10%)*Intelence tablet(s) should be swallowed whole. Patients who are unable to swallow the Intelence tablet(s) whole may disperse the tablet(s) in a glass of water *Information on dosing in pediatric patients 6 - <18 years and weighing at least 16 kg, dispersing tablet in water, adverse reactions, and clinical trial *Postmarketing study Antiviral
03/23/2012 QNASL beclomethasone dipropionate Treatment of nasal symptoms associated with seasonal and perennial allergic rhinitis "Safety and effectiveness in children 12 years and older have been established "Safety and effectiveness in <12 years have not been established "Corticosteroids may cause a reduction in growth velocity when administered to pediatric patients. Routinely monitor the growth of pediatric patients receiving QNASL Nasal Aerosol "The potential for QNASL Nasal Aerosol to cause reduction in growth velocity in susceptible patients or when given at higher than recommended dosages cannot be ruled out "Information on safety, adverse events and clinical trials "New dosage form Anti-inflammatory, topical
03/14/2012 Natazia estradiol valerate and estradiol valerate/dienogest Treatment of heavy menstrual bleeding in women without organic pathology who choose to use an oral contraceptive as their method of contraception "Safety and efficacy have been established in women of reproductive age. Safety and efficacy for post pubertal adolescents < 18 are expected to be the same as for 18 years and older "Use of this product before menarche is not indicated "New indication Contraceptive
03/01/2012 Ultresa pancrelipase Treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions "Safety and efficacy assessed in 2 studies that included patients 7--17 years "Safety and efficacy of pancreatic enzyme products with different formulations of the same active ingredient for use in children have been described in medical literature and through clinical experience "High doses of pancreatic enzyme products have been associated with fibrosing colonopathy in children <12 years of age " Adverse reactions similar to adults "Use in children is limited by the available capsule dosage strengths and their ability to provide the recommended dose based on age and weight. Attempting to divide the capsule contents in small fractions to deliver small doses of lipase is not recommended "Children > 12 months and < 4 years, weighing < 14 kg and children e 4 years, weighing < 28 kg should not be dosed with this product because capsule dosage strengths cannot adequately provide dosing for these children "Capsule should be swallowed whole. Capsule and contents should not be crushed or chewed. For infants or patients unable to swallow intact capsules, the contents may be sprinkled on soft acidic food such as applesauce and swallowed immediately "Information on dosing and clinical studies "Not interchangeable with other pancrelipase products "New drug Pancreatic enzyme
02/29/2012 FluMist Quadrivalent Influenza Vaccine Live, Intranasal* Active immunization for the prevention of disease caused by influenza See Package Insert for new information on biologics Vaccine
02/09/2012 Famvir famciclovir Recurrent herpes labialis "Efficacy has not been established in pediatric patients for the treatment of recurrent herpes labialis "Information on an open label PK, safety and efficacy study in children 12 to <18 years with recurrent herpes labialis added to Pediatric Use subsection of labeling"Postmarketing study Antiviral
02/07/2012 Sklice ivermectin Topical treatment of head lice infestations "Safety and effectiveness in children 6 months and older have been established "Safety has not been established in pediatric patients < 6 months. Sklice Lotion is not recommended in pediatric patients <6 months of age because of the potential increased systemic absorption and risk of ivermectin toxicity" Information on dosage and administration, adverse reactions, pharmacokinetics and clinical trials"New drug Pediculocide, topical
01/25/2012 TISSEEL Fibrin Sealant* Hemostasis: An adjunct to hemostasis in patients undergoing surgery when control of bleeding by conventional surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. TISSEEL is effective in heparinized patients. Sealing: An adjunct to standard surgical techniques (such as suture and ligature) to prevent leakage from colonic anastomoses following the reversal of temporary colostomies See Package Insert for new information on biologics Wound healing
01/18/2012 Viread tenofovir disoproxil fumarate Treatment of HIV infection in combination with other antiretroviral agents *Viread tablets: Expanded the indication from adults to pediatric patients 2 - < 12 years, weighing greater than or equal to 17 kg, who can swallow an intact tablet; tablet previously approved for use in 12 years and older * Viread Oral Powder: Expanded the indication from adults to pediatric patients 2 years of age and older * Safety and effectiveness in patients <2 years have not been established *Viread oral powder should be mixed in a container of soft food not requiring chewing (e.g., applesauce, baby food, yogurt) and ingested immediately to avoid a bitter taste *Adverse reactions were similar to those observed in adults *Postmarketing study, new dosage form Antiviral
12/21/2011 Isentress raltegravir In combination with other antiretroviral agents for the treatment of HIV-1 infection *Isentress Chewable tablets: Expanded indication from adults to pediatric patients 2 - < 12 years and weighing at least 10kg *Isentress Tablets: Expanded indication from adults to pediatric patients 6-18 years *Safety and effectiveness in patients <2 years have not been established*Because the formulations are not bioequivalent, do not substitute chewable tablets for the 400 mg film-coated tablet *Safety profile similar to that observed in adults *Information on dosing, adverse reactions, clinical trial and PK parameters *New dosage form Antiviral
12/16/2011 Keppra levetiracetam Adjunctive therapy in the treatment of partial onset seizures * Expanded indication to include pediatric patients from 1 month - <4 years; previously approved for use in 4 years and older* In pediatric patients 1 month - < 4 years of age, 17% experienced psychotic symptoms compared to 5% on placebo; irritability was reported in 11.7% of the Keppra-treated patients compared to 0% of placebo patients* Information on dosing, clinical trial, adverse reactions Anticonvulsant
12/16/2011 Maxalt and Maxalt-MLT rizatriptan Treatment of migraine * Expanded indication to include pediatric patients from 6 - 17 years. Safety and effectiveness in this age group was established in an adequate and well-controlled trial.* Safety and effectiveness in pediatric patients under 6 years of age have not been established.* Efficacy and safety of treatment with more than one dose of Maxalt within 24 hours in patients 6 to 17 years of age have not been established* Maxalt should not be prescribed to propranolol-treated pediatric patients who weigh < 40 kg (88 lb)* The incidence of adverse reactions in the pediatric clinical trial was similar between treatment and placebo groups. The adverse reaction pattern in pediatric patients is expected to be similar to adults* Hallucination, abnormal coordination, disturbance in attention, and presyncope occurred infrequently in pediatric patients in the clinical trial * Information on dosing, adverse reactions, clinical trial, and overdose Antimigraine
12/16/2011 Prezista darunavir Treatment of HIV-1 infection in adults and pediatric patients 3 years of age and older and weighing at least 10 kg * Expanded indication to pediatric patients 3 years and older weighing at least 10 kg; previously approved for use in 6 years and older* Do not use in pediatric patients < 3 years of age* Information on dosing, adverse reactions, pharmacokinetics and clinical trial* New formulation Antiviral
12/15/2011 Nexium esomeprazole Erosive esophagitis due to acid-mediated gastroesophageal reflux disease * Expanded age range to include pediatric patients 1 month to <1 year. Previously approved in 1-17 years. Use in 1 month to <1 year is supported by extrapolation of studies for adults and safety, pharmacokinetic, and pharmacodynamic studies performed in pediatric patients * Safety and effectiveness have not been established in neonates* Information on weight-based dosing, adverse reactions, clinical study Antiulcerative
12/14/2011 Advate Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method* Routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children (0-16 years) with hemophilia A See Package Insert for new information on biologics Antihemophilic Factor
11/10/2011 HEMACORD hematopoietic progenitor cells, cord blood* For use in unrelated donor hematopoietic progenitor cell transplantation procedures in conjunction with an appropriate preparative regimen for hematopoietic and immunologic reconstitution in patients with disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment See Package Insert for new information on biologics Somatic Cell
11/09/2011 Chantix varenicline Smoking cessation * Safety and effectiveness of Chantix in pediatric patients have not been established; Chantix is not recommended for use in patients < 18 years of age* Information on single and multiple-dose pharmacokinetics of varenicline have been investigated in pediatric patients 12 - 17 years * Postmarketing study Smoking cessation
10/18/2011 Ixempra Kit ixabepilone Advanced or refractory solid tumors * The effectiveness in pediatric patients has not been established * Ixempra was evaluated in one Phase 1 and one Phase 2 trial * Adverse reactions were similar to adults, and no new safety signals were identified Antineoplastic
10/17/2011 Reyataz atazanavir Treatment of HIV - 1 infection * Revised pediatric dosing; Unified dosing for treatment-naive and treatment experienced patients and extended the use of ATV/RTV to treatment-experienced patients weighing 15 to 25 kg* New dosing regimen Antiviral
08/22/2011 Copegus and PEGASYS ribavirin and peginterferon alfa-2a Treatment of chronic hepatitis C in patients 5 to 17 years of age * Extended indication from adults to pediatric patients 5-17 years* Safety and effectiveness of PEGASYS, alone or in combination with COPEGUS in patients < of 5 years have not been established* Pediatric patients treated with PEGASYS plus COPEGUS combination therapy showed a delay in weight and height increases after 48 weeks of therapy compared with baseline. At the end of 2 years follow-up after treatment, most patients returned to baseline normative growth curve percentiles for weight and height* Decreases in hemoglobin, neutrophils and platelets may require dose reduction or permanent discontinuation from treatment * If toxicities occur which may be related to PEGASYS or COPEGUS administration, the dose of one or both can be modified* Adverse reactions were similar to adults* Information on dosing, clinical trial, and adverse reactions Antiviral
07/22/2011 GAMMAGARD LIQUID Immune Globulin Infusion (Human)* Treatment of patients with primary immunodeficiency associated with defects in humoral immunity in adults and pediatric patients two years of age or older See Package Insert for new information on biologics Immunomodulator
07/19/2011 CERVARIX Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant* Postmarketing Study See Package Insert for new information on biologics Preventive Vaccine
07/15/2011 Topamax topiramate Monotherapy for partial onset or primary generalized tonic-clonic seizures * Expanded age range down to 2 years; previously approved for monotherapy for partial onset or primary generalized tonic-clonic seizures in patients10 years and older * Information on weight based dosing in 2 to < 10 years* Postmarketing study Anticonvulsant
06/15/2011 Zenpep pancrelipase Postmarketing study * New dosage strength of 3,000 USP lipase units to allow for dosing in infants less than 12 months* Postmarketing study Pancreatic enzyme
06/10/2011 Creon pancrelipase Postmarketing study * New dosage strength of 3,000 USP lipase units to allow for dosing in infants less than 12 months* Postmarketing study Pancreatic enzyme
06/01/2011 KEDBUMIN Albumin (Human)* Hypovolemic shock, Hypoalbuminemia, Prevention of central volume depletion after paracentesis due to cirrhotic ascites, Ovarian Hyperstimulation Syndrome (OHSS), Adult Respiratory Distress Syndrome (ARDS), Burns, Hemodialysis patients undergoing long term dialysis, Patients who cannot tolerate substantial volumes of salt solution, Priming solution for cardiopulmonary bypass See Package Insert for new information on biologics albumin
05/17/2011 Faslodex Injection fulvestrant Use in girls with progressive precocious puberty associated with McCune-Albright Syndrome * Efficacy has not been demonstrated in girls with McCune-Albright Syndrome associated with progressive precocious puberty* Information on dosing, adverse reactions, pharmacokinetics and clinical trial Estrogen lowering agent
05/06/2011 Plavix clopidogrel bisulfate Reduction of the incidence of thrombosis in children with systemic to pulmonary artery shunts for palliation of cyanotic congenital heart disease * Safety and effectiveness in pediatric populations have not been established* A randomized, placebo-controlled trial did not demonstrate a clinical benefit in neonates and infants with cyanotic congenital heart disease palliated with a systemic-to-pulmonary arterial shunt. Platelet inhibitor
04/29/2011 Nexium IV esomeprazole Treatment of Gastroesophageal Reflux Disease (GERD) with erosive esophagitis * Extended indication from adults to pediatric patients 1 month to 17 years * Use in pediatric patients 1 month to 17 years is supported by studies in adults, and PK and PD studies performed in pediatric patients* Effectiveness has not been established in patients less than 1 month of age* Information on dosing, adverse reactions, pharmacokinetics and clinical trial* Postmarketing study Antiulcerative
04/29/2011 Kytril Injection granisetron hydrochloride Prevention of postoperative nausea and vomiting * Safety and efficacy have not been established in pediatric patients for the prevention of postoperative nausea and vomiting (PONV)* Due to the lack of efficacy and the QT prolongation observed in this trial, use for the prevention of PONV in children is not recommended* Information on postmarketing clinical trial, adverse reactions* Postmarketing PREA required study Antiemetic
04/25/2011 Lamictal XR lamotrigine Monotherapy in patients 13 years of age and older with partial seizures who are receiving therapy with a single antiepileptic drug (AED) * Approved for conversion to monotherapy in patients e13 years of age with partial seizures receiving treatment with a single antiepileptic drug (AED).* Safety and effectiveness have not been established (1) as initial monotherapy or (2) for simultaneous conversion to monotherapy from two or more concomitant AEDs* Information on conversion to monotherapy, adverse reactions, clinical trial* New indication Anticonvulsant
04/22/2011 Menactra Meningococcal Polysaccharide (Serogroups A, C, Y and W-135) Diphtheria Toxoid Conjugate Vaccine)* Active immunization of individuals 9 months through 55 years of age for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135 See Package Insert for new information on biologics Preventive Vaccine
04/15/2011 Actemra tocilizumab Treatment of active Systemic Juvenile Idiopathic Arthritis (SJIA) * Approved for the treatment of active SJIA in patients 2 years and older* Safety and effectiveness in pediatric patients with conditions other than SJIA have not been established* Children < 2 years have not been studied* Interruption of dosing may be needed for management of dose-related laboratory abnormalities including elevated liver enzymes, neutropenia, and thrombocytopenia* Liver enzyme elevation, low neutrophil count, low platelet count and lipid elevations are noted with Actemra treatment in the SJIA population. * The most common adverse events Actemra treated patients in the controlled portion of the study were upper respiratory tract infection, headache, nasopharygitis and diarhea* Information on dosing, lab parameters, adverse reactions, clinical trial* New indication Biological response modifier
04/06/2011 Invega paliperidone Treatment of schizophrenia * Extended treatment of schizophrenia indication from adults to adolescents 12-17 years* Safety and effectiveness for the treatment of schizophrenia in patients < 12 years have not been established. * Safety and effectiveness for the treatment of schizoaffective disorder in patients < 18 years have not been studied * In the adolescent schizophrenia trial, there was no clear enhancement to efficacy at escalation to higher doses (e.g., 6 mg for patients weighing less than 51 kg and 12 mg for patients weighing 51 kg or greater) while adverse events were dose-related* In the 6-week, placebo-controlled study in adolescents with schizophrenia, the incidences of extrapyramidal symptoms related adverse events showed a similar dose-related pattern to those in the adult studies. There were notably higher incidences of dystonia, hyperkinesia, tremor, and parkinsonism in adolescents as compared to the adult studies* Adverse reactions in the adolescent trial included somnolence, akathisia, tremor, dystonia, cogwheel rigidity, anxiety, weight gain, and tachycardia* Information on dosing, adverse events, clinical trial Antipsychotic
03/17/2011 Alimta pemetrexed disodium Refractory and recurrent solid tumors, including osteosarcoma, Ewing sarcoma/peripheral PNET, rhabdomyosarcoma, and neuroblastoma * Efficacy in pediatric patients has not been demonstrated* No responses were observed among the 72 patients in the Phase 2 trial* Information on dosing, clinical trial, adverse events and pharmacokinetics Antineoplastic
03/14/2011 Gadavist gadobutrol Detect and visualize areas with disrupted blood brain barrier (BBB) and/or abnormal vascularity of the central nervous system * Safety and efficacy have been established in children 2 - 17 years* Safety and effectiveness have not been established in children <2 years* Information on dosing, adverse events, pharmacokinetics, and clinical trials Medical imaging
02/25/2011 Intuniv guanfacine Adjunctive treatment with long-acting oral psychostimulants for the treatment of ADHD * Approved for use as adjunctive therapy with stimulants for the treatment of ADHD in pediatric patients 6 years and older* Information on adverse reactions and clinical trial* New indicatio Non-stimulant ADHD treatment
02/17/2011 Hizentra Globulin Subcutaneous (Human), 20% Liquid * Postmarketing study See Package Insert for new information on biologics Immune Serum
02/03/2011 Makena hydroxyprogesterone caproate Reduce the risk of preterm birth * Safety and effectiveness in pediatric patients <16 years have not been established* A small number of women < 18 years were studied; safety and efficacy are expected to be the same in women aged 16 years and above as for users 18 years and older* Information on clinical trial Progestin
01/28/2011 MENVEO Meningococcal (Groups A, C, Y, and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine* Active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135 See Package Insert for new information on biologics Preventive Vaccine
01/19/2011 Nasonex mometasone Treatment of nasal polyps * Safety and effectiveness for the treatment of nasal polyps in children < 18 years have not been established* A trial in pediatric patients 6 to 17 years did not support the efficacy of Nasonex Nasal Spray in the treatment of nasal polyps * The adverse events were similar to adults* Information on clinical tria Anti-inflammatory, topical
01/18/2011 Natroba spinosad Treatment of head lice infestation in patients 4 years of age and older * Safety and effectiveness have been established in pediatric patients 4 years of age and older * Safety in pediatric patients < 4 years has not been established. * Not recommended in pediatric patients< 6 months because of the potential for increased systemic absorption* Natroba contains benzyl alcohol which has been associated with serious adverse reactions and death in neonates and low birth-weight infants. Premature and low-birth weight infants, as well as patients receiving high dosages, may be more likely to develop toxicity* Information on clinical trials, adverse reactions* New drug Pediculocide, topical
12/22/2010 GARDASIL Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant* Prevention of anal cancer caused by HPV types 16 and 18, and prevention of anal intraepithelial neoplasia (AIN) grades 1, 2, and 3 caused by HPV types included in the vaccine See Package Insert for new information on biologics Preventive Vaccine
12/21/2010 INOmax nitric oxide Prevention of bronchopulmonary dysplasia * INOmax is not indicated for prevention of BPD in preterm neonates d 34 weeks gestational age.* Efficacy for the prevention of BPD in preterm infants was not established in three ldouble-blind, placebo-controlled clinical trials in a total of 2,149 preterm infants * Information on clinical trials, adverse reaction Pulmonary vasodilator
12/15/2010 Uroxatral alfuzosin Elevated detrusor leak point pressure of neurologic origin * Uroxatral is not indicated for use in the pediatric population* Efficacy was not demonstrated in a randomized, double-blind, placebo-controlled, efficacy and safety trial conducted in 172 patients ages 2 to 16 years using pediatric formulations Urology
11/19/2010 Moxeza Ophthalmic Solution moxifloxacin Bacterial conjunctivitis * Approved for use in patients 4 months and older* The safety and effectiveness have not been established in patients <4 months of age * There is no evidence that the ophthalmic administration of moxifloxacin has any effect on weight bearing joints, even though oral administration of some quinolones has been shown to cause arthropathy in immature animals* Information on clinical study, adverse reactions* New dosage form Antibiotic
11/12/2010 Synercid quinopristin/dalfopristin Postmarketing study *Labeling updated to revise pediatric dosing in 12 to less than 18 years. No dosing recommendations in pediatric patients less than 12 years * Postmarketing study Antibiotic
11/10/2010 Vyvanse Capsules lisdexamfetamine ADHD * Expanded indication to include adolescent patients ages13-17 years; previously approved for use in 6-12 years * Most common adverse reactions were decreased appetite, insomnia, and decreased weight* Information on clinical trial, adverse reactions CNS Stimulant
11/02/2010 Ofirmev acetaminophen Management of mild-to-moderate pain, for the management of moderate-to-severe pain with adjunctive opioid analgesics, and for the reduction of fever * The safety and effectiveness of Ofirmev for the treatment of acute pain and fever in pediatric patients ages 2 years and older is supported by evidence from adequate and well-controlled studies of Ofirmev in adults. Additional safety and PK data was collected in 355 from premature neonates to adolescents. * The effectiveness of Ofirmev for the treatment of acute pain and fever has not been studied in pediatric patients < 2 years of age.* The PK exposure of Ofirmev observed in children and adolescents is similar to adults, but higher in neonates and infants. Dosing simulations from PK data in infants and neonates suggest that dose reductions of 33% in infants 1 month to < 2 years of age, and 50% in neonates up to 28 days, with a minimum dosing interval of 6 hours, will produce a PK exposure similar to that observed in children age 2 years and older* Most common adverse reactions in pediatric patients were nausea, vomiting, constipation, pruritus, agitation, and atelectasis.* Information on dosing, clinical studies, adverse reactions and PK parameters* New dosage form and route of administration Analgesic; Antipyretic
10/29/2010 Afinitor everolimus Treatment of patients with subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis * Approved for treatment of patients with SEGA associated with TS * An open-label, single-arm safety and efficacy trial was conducted in 28 patients 3-34 years with SEGA associated with TS * Afinitor has not been studied in patients with SEGA < 3 years of age* Most common adverse reactions (incidence e30%) were stomatitis, upper respiratory tract infection, sinusitis, otitis media, and pyrexia* Dose reduction and/or treatment interruption may be needed to manage adverse drug reactions * Information on starting dose, therapeutic drug monitoring, clinical trial, and adverse reactions * New indication Antineoplastic
10/21/2010 Lo Loestrin Fe norethindrone acetate/ ethinyl estradiol Prevention of pregnancy * Safety and efficacy have been established in women of reproductive age. Safety and efficacy are expected to be the same for postpubertal adolescents <18 years and for users e18 years * Use before menarche is not indicated* New dose and dosing regimen Contraceptive
10/05/2010 Aridol Powder for Inhalation mannitol Assessment of bronchial hyperresponsiveness in patients without clinically apparent asthma * New indication in patients 6 years and older* Efficacy assessed in a total of 246 children and adolescents 6 to 17 years in 2 clinical trials* Bronchial challenge testing should not be performed in children < 6 years due to their inability to provide reliable spirometric measurements * Adverse events similar to adults* Information on adverse events and clinical studies* New indication, dosage form, and route of administration Diagnostic aid
09/28/2010 Kapvay Extended Release Tablets clonidine Treatment of attention deficit hyperactivity disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications * New indication in children 6 years and older* Efficacy is based on 2 clinical trials in children and adolescents 6 -17 years * Kapvay has not been studied in children with ADHD < 6 years* Kapvay can cause dose related decreases in blood pressure and heart rate* Common adverse events reported in clinical trials included somnolence, fatigue, upper respiratory tract infection irritability, throat pain, insomnia, nightmares, emotional disorder. In fixed dose pediatric monotherapy study, 31% of patients treated with 0.4 mg/day and 38% treated with 0.2 mg/day vs 7% of placebo treated patients reported somnolence. * Kapvay is an extended-release tablet formulation of clonidine; therefore, it is not to be used interchangeably with the immediate-release formulation* Information on adverse events, and clinical trials*New indication Non-stimulant ADHD treatment
09/24/2010 Beyaz drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium Prevention of pregnancy; premenstrual dysphoric disorder; moderate acne vulgaris e14 years who have achieved menarche; to raise folate levels in a pregnancy conceived while on or shortly after discontinuing the product * Safety and efficacy have been established in women of reproductive age. Safety and efficacy are expected to be the same for postpubertal adolescents <18 years and for users e18 years * Use before menarche is not indicated * New combination Contraceptive
09/08/2010 Protopam** pralidoxime Treatment of poisoning due to organophosphates (e.g., nerve agents) * Expanded indication from adults to pediatrics * Efficacy extrapolated from adult population and supported by nonclinical studies, PK studies in adults and experience in the pediatric population * Information on IV and IM dosing, and adverse events Antidote
08/27/2010 Augmentin XR amoxicillin/clavulanate potassium Community-acquired pneumonia or acute bacterial sinusitis * Expanded indication from adults to children weighing e 40 kg who are able to swallow tablets * Use in children is supported by evidence from trials of adults with additional data from a pediatric PK study * Adverse events similar to adults * Information on dose, and PK parameters * Information added to Clinical Pharmacology and Pediatric Use Antibiotic
08/13/2010 ella ulipristal acetate Prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure * Safety and efficacy have been established in women of reproductive age. Safety and efficacy are expected to be the same for post pubertal adolescents <18 years and for users 18 years and older. * Use of ella before menarche is not indicated * New drug Contraceptive
07/28/2010 Lastacaft Ophthalmic Solution alcaftadine Prevention of itching associated with allergic conjunctivitis. * Safety and effectiveness in patiente 2 years were established in controlled clinical trials * Safety and effectiveness in pediatric patients< 2 years have not been established * New drug Antihistamine, topical
06/29/2010 Daytrana methylphenidate ADHD * Expanded pediatric indication to include adolescent patients ages13-17 years * The most commonly reported adverse reactions in a trial in patients 13-17 years included appetite decreased, nausea, insomnia, weight decreased, dizziness, abdominal pain, and anorexia. The majority of patients had erythema at the application site * Information on PK parameters, Adverse Event profile and clinical studies CNS Stimulant
06/25/2010 Serevent salmeterol Asthma * Available data from controlled clinical trials suggest that Long Acting Beta Agonists (LABAs) increase the risk of asthma-related hospitalization in pediatric and adolescent patients. For pediatric and adolescent patients with asthma who require addition of a LABA to an inhaled corticosteroid, a fixed-dose combination product containing both an inhaled corticosteroid and LABA should ordinarily be used to ensure adherence with both drugs. In cases where use of a separate long-term asthma control medication (e.g. inhaled corticosteroid) and LABA is clinically indicated, appropriate steps must be taken to ensure adherence with both treatment components. Antiasthmatic
06/22/2010 Dulera Inhalation Aerosol mometasone furoate and formoterol fumarate Asthma * Safety and effectiveness have been established in patients 12 years and older in 3 clinical studies * Safety and efficacy have not been established in children <12 years * Data from clinical trials suggest that LABA increase the risk of asthma-related hospitalization in pediatric and adolescent patients * Information on adverse events and clinical studies * New combination Antiasthmatic
06/22/2010 Isopto Carpine pilocarpine hydrochloride Reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension; management of acute angle closure glaucoma; prevention of postoperative elevated IOP associated with laser surgery and induction of miosis * Safety and effectiveness in pediatric patients have been established * Not recommended in pediatric patients diagnosed with glaucoma due to anterior segment dysgenesis or uveitis * Caution is advised in pediatric patients with primary congenital glaucoma for control of IOP as cases of a paradoxical increase in IOP have been reported. * Adverse events similar to adults * New dosage form Ophthalmologic hypotensive
06/03/2010 Zylet loteprednol etabonate and tobramycin Eye lid inflammation *Efficacy was not demonstrated in a study of pediatric patients 0-6 years Anti-inflammatory, Antibiotic
05/26/2010 Nasonex mometasone Nasal congestion associated with seasonal allergic rhinitis * New indication in pediatric patients 2 years and older * Safety and effectiveness evaluated in 3 clinical studies in 12 years and older. Use in pediatric patients 2 - 11 years is supported by data from other pediatric clinical studies * Safety and effectiveness for any use in patients < 2 years have not been established * Information on dosing, adverse reactions, and clinical studies in 12 years and older * New indication Anti-inflammatory, topical
05/18/2010 Zymaxid gatifloxacin Bacterial conjunctivitis * Safety and effectiveness have been demonstrated in clinical trials for the treatment of bacterial conjunctivitis in pediatric patients 1 year and older * The safety and effectiveness in infants < 1year have not been established * Information on adverse reactions and clinical trials * New drug Antibiotic
05/13/2010 Taxotere docetaxel Solid Tumors * Efficacy in pediatric patients as monotherapy or in combination has not been established. * Taxotere has been studied in a total of 289 pediatric patients: 239 in 2 trials with monotherapy and 50 in combination treatment with cisplatin and 5-fluoruracil * The overall safety profile in pediatric patients receiving monotherapy or combination treatment was consistent with the safety profile in adults * Information on dosing, clinical trials and PK parameters Antineoplastic
05/07/2010 Omnaris Nasal Spray ciclesonide Postmarketing study * Information on clinical study to assess effect of orally inhaled ciclesonide on growth Antiasthmatic; antiallergy
05/06/2010 Natazia estradiol valerate and estradiol valerate/dienogest Prevention of pregnancy * Safety and efficacy have been established in women of reproductive age. Safety and efficacy for post pubertal adolescents < 18 are expected to be the same as for 18 years and older * Use of this product before menarche is not indicated * New drug Contaceptive
04/12/2010 Pancreaze pancrelipase Treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions * Safety and efficacy assessed in 2 studies that included patients 6-30 months and 8--17 years * Safety and efficacy for use in all pediatric age groups based on information from the literature and clinical experience with different formulations of pancrelipase containing the same active ingredient * High doses of pancreatic enzyme products have been associated with fibrosing colonopathy in children <12 years of age * Adverse reactions similar to adults * Capsule should be swallowed whole. For infants or patients unable to swallow intact capsules, the contents may be sprinkled on soft acidic food such as applesauce * Information on dosing and clinical studies * Not interchangeable with other pancrelipase products * New drug Pancreatic enzyme
03/24/2010 Viread tenofovir disoproxil fumarate Treatment of HIV infection in combination with other antiretroviral agents * Expanded indication from adults to pediatric patients 12- <18 years * Safety and effectiveness in patients < 12 years have not been established * In a clinical study of HIV-1 infected adolescents bone effects were similar to adults * The adverse reactions in trial in adolescents were consistent with those observed in clinical trials in adults * Information on dosing in adolescents weighing e35 kg, adverse reactions, and PK parameters Antiviral
03/17/2010 Differin Lotion adapalene Acne * Safety and effectiveness established in 2 clinical studies in patients 12 years and older * Safety and effectiveness in pediatric patients less than 12 years have not been established * New dosage form Antiacne, topical
03/17/2010 MultiHance Injection gadobenate dimeglumine Intravenous use in magnetic resonance imaging * Extended indication from adults to pediatric patients 2 years and older * Safety and effectiveness in pediatric patients less than 2 years have not been established * Patients less than 2 years may be at increased risk of nephrogenic systemic fibrosis related to gadolinium due to immature kidney function * Adverse events similar to adult patients * Information on adverse events, PK, and clinical studies * New indication Diagnostic aid
02/24/2010 Prevnar 13 Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein) * Active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F, and for the prevention of otitis media caused by serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F See Package Insert for new information on biologics Preventive Vaccine
02/22/2010 TamiFlu oseltamivir Prophylaxis of influenza * Information on postmarketing clinical study in patients 1 to 12 years Antiviral
02/19/2010 MENVEO Meningococcal (Groups A, C, Y, and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine* Active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135 See Package Insert for new information on biologics Preventive Vaccine
02/04/2010 Benicar olmesartan Hypertension * Expanded indication from adults to pediatric patients 6 years and older * Information on preparation of an oral suspension * Adverse events similar to adult patients * Information on dosing, adverse reactions, pharmacokinetics, and clinical studies Antihypertensive
01/29/2010 Lamictal XR lamotrigine Adjunctive therapy for Primary Generalized Tonic-Clonic seizures * New indication for adjunctive therapy for primary generalized tonic-clonic seizures in patients e 13 years of age * Safety and effectiveness for any use in patients < 13 years have not been established * Information on dosing, adverse reactions, and clinical studies Anticonvulsant
01/25/2010 Sandostatin and Sandostatin LAR octreotide Weight loss due to hypothalamic obesity from cranial insult * Post-marketing reports of hypoxia, necrotizing enterocolitis, and death in children added to Pediatric Use. The relationship of these events to octreotide has not been established. * Pediatric Use subsection of Sandostatin labeling harmonized with Sandostatin LAR labeling Endocrine agent
01/04/2010 Xolair omalizumab Moderate to severe persistent asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids. * Safety and effectiveness were evaluated in 2 studies in 926 asthma patients 6 to <12 years of age. The risk-benefit assessment does not support use in patients 6 to <12 years considering the risk of anaphylaxis and malignancy seen in Xolair-treated patients e12 years and the modest efficacy of Xolair in the pivotal pediatric study * Studies in patients 0-5 years were not required due to safety concerns of anaphylaxis and malignancy * Information added to Pediatric Use Antiasthmatic
12/24/2009 Famvir famciclovir Treatment of children 1 month  12 years of age w/ herpes simplex (HSV) & 1  12 years w/ varicella zoster (VSV) * Available data are insufficient to support the use of famciclovir for the treatment of children with chickenpox or infections due to HSV * The PK profile and safety were studied in 2 open-label studies: (1) a single-dose PK and safety study in infants 1 month to <1 year of age who had an active herpes simplex virus (HSV) infection or who were at risk for HSV infection and (2) a single-dose PK, multiple-dose safety study in children 1 to <12 years of age with clinically suspected HSV or varicella zoster virus (VZV) infection * Information added to Pediatric Use Antiviral
12/22/2009 Flomax tamsulosin Treatment of elevated detrusor leak point pressure associated with neurological disorder * Efficacy and positive benefit/risk was not demonstrated in 2 studies (a randomized, double-blind, safety and efficacy study and an open label safety study) conducted in patients 2 -16 years * The most frequently reported adverse events from the 2 studies were urinary tract infection, vomiting, pyrexia, headache, nasopharyngitis, cough, pharyngitis, influenza, diarrhea, abdominal pain, and constipation. * Information added to Pediatric Use Urology
12/22/2009 Topamax topiramate Migraine Prophylaxis * Safety and effectiveness for migraine prevention in pediatric patients have not been established * Dose-related increased shift in serum creatinine in adolescent patients occurred in a clinical study * Information added to Warnings and Precautions and Pediatric Use Anticonvulsant
12/22/2009 Topamax topiramate Adjunctive Treatment for Partial Onset Epilepsy in Infants and Toddlers 1 to 24 months * Effectiveness was not demonstrated as adjunctive therapy in a randomized, double-blind trial in infants/toddlers 1 to 24 months of age with refractory partial onset seizures * Trials in infants/toddlers 1 to 24 months suggested some adverse reactions/toxicities not previously observed in older pediatric patients and adults; i.e, growth/length retardation, certain clinical laboratory abnormalities, and other adverse reactions/toxicities that occurred with a greater frequency and/or greater severity than had been recognized previously from studies in older pediatric patients or adults for various indications. * Information added to Warnings and Precautions and Pediatric Use Anticonvulsant
12/14/2009 Daytrana methylphenidate Postmarketing safety study * Information added to Warnings and Adverse Reactions on skin reactions observed in a postmarketing dermal study in pediatric patients CNS Stimulant
12/04/2009 Zyprexa olanzapine Treatment of manic or mixed episodes of bipolar I disorder and schizophrenia in adolescents ages 13-17 * Extended schizophrenia and manic or mixed episodes of bipolar I disorder indications from adults to adolescents 1317 years of age * Safety and effectiveness in children < 13 years of age have not been established * Recommended starting dose for adolescents is lower than that for adults * Compared to patients from adult clinical trials, adolescents were likely to gain more weight, experience increased sedation, and have greater increases in total cholesterol, triglycerides, LDL cholesterol, prolactin and hepatic transaminase levels * Information on dosing, adverse reactions, pharmacokinetics, clinical studies Antipsychotic
12/02/2009 Seroquel quetiapine Treatment of schizophrenia in adolescents 13 to 17 years of age and the treatment of bipolar mania in children and adolescents 10 to 17 years of age * Extended schizophrenia indication from adults to adolescents 1317 years of age; extended bipolar mania indication from adults to children and adolescents 10-17 years of age * Safety and effectiveness in children < 13 years of age with schizophrenia have not been established; safety and effectiveness in children < 10 years of age with bipolar mania have not been established * Most adverse reactions in pediatric clinical trials were similar to those observed in adults and included somnolence, dizziness, fatigue, increased appetite, nausea, vomiting, dry mouth, tachycardia, and weight increase. However, increases in blood pressure and potentially clinically significant increases in heart rate (> 110 bpm) occurred in children and adolescents and did not occur in adults. * Information on dosing, adverse reactions, pharmacokinetics, and clinical studies Antipsychotic
12/01/2009 Patanase olopatadine Seasonal allergic rhinitis * Expanded age range down to 6 years; previously approved for use in 12 years and older * Safety and effectiveness have not been established in < 6 years of age * The incidence of epistaxis (nosebleed) was higher in children 6 -11 years of age compared to the adult and adolescent population * Information on clinical trials, adverse reactions, and new one spray per nostril twice daily dosing in 6-11 years Antihistamine
11/19/2009 Abilify aripiprazole Irritability associated with autistic disorder * Safety and effectiveness in pediatric patients demonstrating irritability associated with autistic disorder were established in two placebo-controlled clinical trials in pediatric patients 6 - 17 years of age * Most common adverse reactions observed in pediatric clinical trials in patients with autistic disorder included sedation, fatigue, vomiting, somnolence, tremor, pyrexia, drooling, decreased appetite, salivary hypersecretion, extrapyramidal disorder, and lethargy. Fatigue was a possible dose-response adverse reaction. * Information on dosing, adverse reactions, and clinical studies Antipsychotic
11/12/2009 Protonix pantoprazole GERD * Extended indication from adults to pediatric patients 5 years of age and older * Use in pediatric patients 1 to 16 years of age is supported by extrapolation from studies in adults, and safety, efficacy and PK studies performed in pediatric patients * There is no age-appropriate formulation available for patients less than 5 years of age * Effectiveness was not demonstrated in a clinical trial of patients 1 month to 11 months of age with symptomatic GERD * Safety and effectiveness for pediatric uses other than EE have not been established * Information on adverse reactions, pharmacokinetics, and clinical studies Antiulcerative
11/10/2009 AFLURIA Influenza Virus Vaccine* Active immunization for the prevention of influenza disease caused by virus types A and B contained in the vaccine See Package Insert for new information on biologics Preventive Vaccine
11/06/2009 Retrovir zidovudine Treatment of HIV-1 infection in combination with other antiretroviral agents * Provided dosing recommendations for patients 4 weeks to < 6 weeks of age and weighing 4 kg to < 9 kg Antiviral
10/23/2009 Focalin XR dexmethylphenidate ADHD * Revised maximum daily dosing due to dose-response studies. Doses above 30 mg/day in pediatrics and 40 mg/day in adults have not been studied and are not recommended * Dosing should be individualized to patient needs and response. * There was no clear benefit of the higher doses compared to the lower doses. Adverse events and discontinuations were dose-related. * New dosing regimen; new dosage strength (30 mg capsule) CNS Stimulant
10/22/2009 Atacand candesartan Hypertension * Expanded indication from adults to pediatric patients 1 to < 17 years of age. * Children < 1 year must not receive candesartan. Administering drugs that act directly on the renin-angiotensin system can have effects on the development of immature kidneys * Children with glomerular filtration rate < 30ml/min/1.73m2 should not receive candesartan. * In clinical trials, 4 of 233 children experienced worsening renal disease * Information on preparation of an oral suspension, dosing and administration, adverse events, pharmacokinetics, and clinical trials Antihypertensive
10/19/2009 Fluarix Influenza Virus Vaccine* Active immunization for the prevention of influenza disease caused by virus types A and B contained in the vaccine See Package Insert for new information on biologics Preventive Vaccine
10/16/2009 CERVARIX Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant* Prevention of genital warts caused by HPV 16 and 18 See Package Insert for new information on biologics Preventive Vaccine
10/16/2009 GARDASIL Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant* Prevention of genital warts caused by HPV 6 and 11 See Package Insert for new information on biologics Preventive Vaccine
10/15/2009 Crestor rosuvastatin Heterozygous familial hypercholesterolemia * New indication in adolescent boys and girls (at least one year post-menarche) 10-17 years with heterozygous familial hypercholesterolemia * Has not been studied in children < 10 years or in pre-menarchal girls * Information on dose, adverse events and clinical studies Antilipemic
10/02/2009 Welchol colesevelam Heterozygous familial hypercholesterolemia * New indication for use as monotherapy or with a statin in boys and postmenarchal girls 10-17 years with heterozygous familial hypercholesterolemia * Has not been studied in children < 10 years or in pre-menarchal girls * Information on dose, adverse events and clinical studies Antilipemic
10/01/2009 Mirena levonorgestrel-releasing intrauterine system Treatment of heavy menstrual bleeding for women using intrauterine contraception * New indication for the treatment of heavy menstrual bleeding for women who choose to use intrauterine contraception * Use before menarche is not indicated Contaceptive
09/18/2009 AndroGel testosterone Use in adolescent boys with delayed puberty * New safety information added to labeling including a Boxed Warning, and revisions to the Warnings and Precautions, Adverse Reactions, and Patient Counseling sections on the risk of virilization from secondary exposure of children to testosterone due to drug transfer from unwashed or uncovered application skin sites of adult males using testosterone gel products * Safety and efficacy have not been established in males < 18 years Androgen-anabolic steroid
09/08/2009 Bepreve Ophthalmic Solution bepotastine besilate Ocular itching associated with allergic conjunctivitis * Efficacy in pediatric patients 2 years to < 10 years based on clinical trials conducted in pediatric patients > 10 years and from adults * Safety and efficacy have not been established in pediatric patients < 2 years * New drug Antihistamine, topical
09/02/2009 Intuniv guanfacine ADHD * Efficacy established in 2 controlled clinical trials in children 6-17 years * Safety and efficacy in pediatric patients< 6 years have not been established * In clinical trials, there were dose and exposure-related risks for adverse events (AEs) including hypotension, bradycardia, and sedative events. Somnolence and sedation were reported in 38% on guanfacine vs. 12% on placebo in children and adolescents with ADHD, especially during initial use * Information on dosing, clinical trials, and AEs * New dosage form Non-stimulant ADHD treatment
08/31/2009 Astepro Nasal Spray azelastine hydrochloride Seasonal and perennial allergic rhinitis in patients 12 years of age and older. * Safety and efficacy for the treatment of seasonal and perennial allergic rhinitis were evaluated in 7 controlled clinical trials in patients 12 years and older * Information on clinical trials, dosing, and adverse events (AEs) * New indication (PAR) and dosing regimen Antihistamine
08/28/2009 Valcyte valganciclovir Prevention of cytomegalovirus (CMV) disease in pediatric kidney and heart transplant patients e 4 months of age * Use in pediatric patients e 4 months is based on efficacy data from a study in adults and PK, safety, and efficacy data from an open-label trial in pediatric solid organ transplant recipients at risk for developing CMV disease * The efficacy and safety have not been established in children for: 1. Prevention of CMV disease in liver transplant patients 2. Prevention of CMV disease in solid organ transplants other than those indicated 3. Prevention of CMV disease in pediatric solid organ transplant patients < 4 months of age 4. Treatment of congenital CMV disease * Adverse events (AEs) similar to adult patients, however, certain Aes including upper respiratory tract infection, pyrexia, nasopharyngitis, anemia, and neutropenia were reported more frequently in pediatric patients * Information on dosing, PK, and clinical study * New dosage form Antiviral
08/27/2009 Zenpep pancrelipase Exocrine pancreatic insufficiency due to cystic fibrosis * Safety and efficacy assessed in 2 studies which included pediatric patients ages 1-17 years * Safety and efficacy for use in all pediatric age groups based on information from the literature and clinical experience with different formulations of pancrelipase with the same active ingredient. * High doses of pancreatic enzyme products have been associated with fibrosing colonopathy and colonic strictures in children <12 years of age * AEs similar to adults * Capsule should be swallowed whole. For infants or patients unable to swallow intact capsules, the contents may be sprinkled on soft acidic food such as applesauce * Information on dosing, and clinical studies * Not interchangeable with other pancrelipase products * New drug Pancreatic enzyme
08/21/2009 Xyzal levocetirizine dihydrochloride Seasonal allergic rhinitis (SAR) in children 2 years of age and older; perennial allergic rhinitis (PAR) and chronic idiopathic urticaria (CIU) for children 6 months of age and older * Expanded age range for CIU down to 6 months; previously approved for use in 12 years and older * Expanded age range for PAR down to 6 months; previously approved for use in 6 years and older * Expanded age range for SAR down to 2 years; previously approved for use in 6 years and older * Pediatric use is supported by evidence from studies in adults with additional safety and PK data in pediatrics * Patient population altered Antihistamine
08/19/2009 HIBERIX Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) * Active immunization as a booster dose for the prevention of invasive disease caused by Haemophilus influenzae type b See Package Insert for new information on biologics Preventive Vaccine
07/31/2009 Xerese acyclovir/ hydrocortisone Recurrent herpes labialis (cold sores) in 12 years of age and older * Use in adolescents e12 years is supported by evidence from studies in adults with additional safety data in adolescents e12 years * Safety and effectiveness in pediatric patients < 12 years have not been established * Information on clinical studies, and adverse events * New drug Antiviral, topical
07/23/2009 Actonel risedronate Osteogenesis imperfecta * Safety and effectiveness have not been established in pediatric patients * In a 1 year double-blind, placebo controlled study of pediatric patients with osteogenesis imperfecta (OI), treatment with risedronate did not result in a reduction in the risk of fracture * Adverse events similar to those observed in adults except for an increased incidence in vomiting * Information on clinical study Bone density
07/10/2009 Plan B One Step levonorgestrel Emergency contraception - OTC in women 17 years and older; RX for women younger than age 17 years * New single dose 1.5 mg tablet * New dosage regimen Contaceptive
06/18/2009 Nexium esomeprazole Short-term treatment of GERD * Effectiveness was not demonstrated in a randomized, placebo-controlled study in neonates to < 1 year * Information on clinical study, PK/PD parameters Antiulcerative
05/29/2009 Lamictal XR lamotrigine Adjunctive therapy for partial onset seizures in patients e13 years of age * Extended release tablets are indicated as adjunctive therapy for partial onset seizures with or without secondary generalization in patients e13 years * Safety and effectiveness of extended release tablets for any use in patients below the age of 13 have not been established * Information on adverse event profile, and clinical studies * New dosage form Anticonvulsant
05/28/2009 Besivance besifloxacin ophthalmic suspension Treatment of bacterial conjunctivitis * Efficacy in pediatric patients 1 year and older has been demonstrated in controlled clinical trials * Safety and effectiveness in infants < 1 year of age have not been established * There is no evidence that the ophthalmic administration of quinolones has any effect on weight bearing joints * Information on AE profile and clinical study * New drug Antibiotic, topical
05/08/2009 Lamictal lamotrigine Adjunctive treatment for partial seizures in pediatric patients 1  24 months * Safety and effectiveness as adjunctive treatment for partial seizures were not demonstrated in a small randomized, double-blind, placebo-controlled, withdrawal study in pediatric patients 1 - 24 months * Immediate release tablets were associated with an increased risk for infectious adverse reactions including bronchiolitis, bronchitis, ear infection, eye infection, otitis externa, pharyngitis, urinary tract infection, and viral infection (Lamictal 37%, Placebo 5%), and respiratory adverse reactions including nasal congestion, cough, and apnea. (Lamictal 26%, Placebo 5%) Anticonvulsant
05/01/2009 Cetraxal ciprofloxacin otic solution Treatment of acute otitis externa due to susceptible isolates of Pseudomonas aeruginosa or Staphylococcus aureus * Efficacy in pediatric patients 1 year and older has been demonstrated in controlled clinical trials * Safety and effectiveness in infants < 1 year have not been established * There is no evidence that the otic administration of quinolones has any effect on weight bearing joints * Information on AE profile and clinical study * New dosage form Antibiotic, topical
04/30/2009 Axert almotriptan Acute treatment of pediatric migraine in adolescent patients age 12-17 years * Safety and effectiveness established in patients 12  17 years. Efficacy on migraine associated symptoms (nausea, photophobia and phonophobia) was not established. * Safety and effectiveness in pediatric patients < 12 years have not been established * The most common adverse events were dizziness, somnolence, headache, paresthesia, nausea and vomiting. Safety and tolerability similar to adults. * Information on dosing, adverse events, PK parameters, clinical study * Patient population altered Antimigraine
04/30/2009 Creon pancrelipase Exocrine pancreatic insufficiency due to cystic fibrosis or other conditions * Safety and efficacy assessed in a study that included patients 12-18 years * Safety and efficacy for use in all pediatric age groups based on information from the literature and clinical experience with different formulations of pancrelipase containing the same active ingredient. * High doses of pancreatic enzyme products have been associated with fibrosing colonopathy in children <12 years of age * AEs similar to adults * Capsule should be swallowed whole. For infants or patients unable to swallow intact capsules, the contents may be sprinkled on soft acidic food such as applesauce * Information on dosing and clinical study * Not interchangeable with other pancrelipase products * New drug Pancreatic enzyme
04/14/2009 Suprane desflurane Safety study of 2 agents used for maintenance of anesthesia in non-intubated patients * Postmarketing Reports subsection added to the Adverse Events section of labeling, including reports of cardiac disorders. * Postmarketing reports are voluntary; it is not possible to estimate frequency or causality to drug exposure. Anesthetic agent
04/09/2009 Ulesfia Lotion, 5% benzyl alcohol Treatment of head lice * Safety and effectiveness established in pediatric patients 6 months and older * Safety in pediatric patients < 6 months has not been established. * Not recommended in pediatric patients < 6 months due to potential for increased systemic absorption * Neonates are at risk of gasping syndrome due to benzyl alcohol * Adverse events similar to those observed in adults * Information on dosing and administration, warnings and precautions, adverse events, PK parameters, and clinical studies * New drug Pediculocide, topical
03/19/2009 Lexapro escitalopram oxalate Major depressive disorder in adolescents * Safety and effectiveness have been established in adolescents 12 to 17 years for the treatment of MDD. Maintenance efficacy is supported from extrapolation of data from adult studies along with comparisons with racemic citalopram pharmacokinetic parameters in adults and adolescents. * Safety and effectiveness have not been established in pediatric patients <12 years with MDD * Safety and effectiveness have not been established in pediatric patients less than 18 years of age with Generalized Anxiety Disorder * Adverse events generally similar to those observed in adults * Information on dosing, adverse events, PK parameters, and clinical studies * Patient population altered Antidepressant
12/19/2008 Casodex bicalutamide Gonadotropin-independent precocious puberty in boys with familial male-limited precocious puberty (testotoxicosis) * Safety and effectiveness have not been established in pediatric patients * Bicalutamide was studied in combination with anastrozole in an open-label, non-comparative, multi-center study that assessed the efficacy and safety of this combination regimen over 12 months in the treatment of testotoxicosis in patients e2 years * Of the 14 patients exposed to study treatment, 13 had at least one adverse event. Adverse reactions considered possibly related to bicalutamide included gynecomastia (43%), central precocious puberty (14%), breast tenderness (14%), breast pain (7%), asthenia (7%), increased alanine aminotransferase (7%), increased aspartate aminotransferase (7%), and musculoskeletal chest pain (7%). Headache was the only adverse reaction considered possibly related to anastrozole * Information on clinical studies, AEs, and PK parameters Androgen blocker
12/19/2008 Ziagen abacavir HIV infection * Provided new scored tablet for use in pediatric patients weighing >14 kg who can swallow tablets * New dosing regimen Antiviral
12/18/2008 Prezista darunavir Treatment of HIV infection in pediatric patients 6 years and older when co-administered with ritonavir (Prezista/rtv), and with other antiretroviral agents * Extended indication from adults to pediatric patients 6 years and older * Safety and effectiveness in pediatric patients 3 to < 6 years of age have not been established * Do not administer in pediatric patients below 3 years of age * Do not administer Prezista/rtv once daily in pediatric patients * Dosing for patients 6 to < 18 years and weighing at least 44 lbs (20 kg) is based on body weight not to exceed adult dose * AE similar to those seen in adults * Information on dose, Aes, PK parameters, lab abnormalities, and clinical study Antiviral
12/17/2008 Epiduo adapalene and benzoyl peroxide Topical treatment of acne vulgaris in patients 12 years of age and older * Safety and effectiveness established in patients 12 years of age and older * Safety and effectiveness in pediatric patients under the age of 12 have not been established * New drug Antiacne, topical
12/11/2008 PegIntron Peginterferon alfa-2b Co-administered with ritonavir to treat chronic hepatitis C in patients 3 years of age and older with compensated liver disease previously untreated with interferon alpha * Safety and efficacy established in pediatric patients 317 years of age * Safety and effectiveness in patients < 3 years have not been established. * Dosing for pediatric patients is determined by body surface area for peginterferon alfa-2b and by body weight for ritonavir * An open-label study in patients 3 - 17 years showed weight and height gain of pediatric patients treated with combination therapy lags behind that predicted by population data while on treatment. * Adverse events similar to those observed in adults. Most common pediatric adverse events were pyrexia, headache, neutropenia, fatigue, anorexia, injection site erythema, vomiting * Information on PK parameters, and clinical study * New indication Antiviral
12/05/2008 Arimidex anastrozole Male pubertal patients with gynecomastia and female pediatric patients with McCune-Albright syndrome with progressive precocious puberty * Efficacy has not been demonstrated in clinical studies of anastrozole in the treatment of pubertal gynecomastia in adolescent boys 11-18 years and in the treatment of precocious puberty in girls with McCune-Albright Syndrome 2 to < 10 years * Information on clinical studies, AEs, and PK parameters Estrogen lowering agent
11/14/2008 Neulasta Pefilgrastim Decrease the incidence of infection in pediatric patients with sarcoma * Safety and effectiveness in pediatric patients have not been established * Safety and PK were studied in 37 pediatric patients with sarcoma * Information added to Pediatric Use Hematopoietic
10/28/2008 Prevacid lansoprazole Symptomatic GERD in infants * Effectiveness was not established in a 4 week multicenter, double-blind, placebo-controlled study of patients 1 month and < 12 months of age * AE profile similar to that observed in adults* Information on PK parameters in neonates to < 1 year, and clinical studies Antiulcerative
10/24/2008 Apidra insulin glulisine recombinant Diabetes Mellitus * Extended indication from adults to pediatric patients 4 years and older with type 1 diabetes * Has not been studied in pediatric patients less than 4 years with type 1 diabetes and in pediatric patients with type 2 diabetes * Pediatric patients had a higher incidence of severe symptomatic hypoglycemia compared to adults in the clinical study * New indication Antidiabetic
10/21/2008 Acanya Gel clindamycin/ benzoyl peroxide combination Acne vulgaris in patients 12 years of age and older * Safety and effectiveness established in 2 clinical studies in patients 12 years of age and older * Safety and effectiveness in pediatric patients under the age of 12 have not been evaluated * New drug Antiacne, topical
10/14/2008 Zomig Nasal Spray zolmitriptan Migraine * Safety and effectiveness have not been established in pediatric patients less than18 years of age. * A single, multi-center, double-blind randomized placebo-controlled study failed to demonstrate efficacy in pediatric patients ages 12 -17 years for the acute treatment of migraine headaches * Adverse events similar to those observed in adults. Antimigraine
10/10/2008 Kogenate FS Antihemophilic Factor (Recombinant)* Routine prophylaxis to reduce the frequency of bleeding episodes and the risk of joint damage in children with hemophilia A with no pre-existing joint damage See Package Insert for new information on biologics Hematology/Coagulation
10/08/2008 Zmax Oral Susp azithromycin Community-Acquired Pneumonia * Safety and effectiveness established in pediatric patients 6 months of age or older with community-acquired pneumonia. Use is supported by evidence from studies in adults with additional safety and PK data in pediatric patients * Safety and effectiveness in the treatment of pediatric patients < 6 months of age have not been established. * Safety and effectiveness in the treatment of pediatric patients with acute bacterial sinusitis have not been established * Information on dose, PK parameters, AE profile, lab abnormalities, and clinical studies * New indication Antibiotic
10/07/2008 Akten Ophthalmic gel 3.5% lidocaine hydrochloride Ocular surface anesthesia during ophthalmologic procedures * Safety and efficacy extrapolated from studies in adults and older pediatric patients using different ophthalmic formulations of lidocaine. * New dosage form Anesthetic, topical
09/29/2008 Videx EC didanosine HIV infection in >20 kg * Extended indication from adults to children weighing e20kg who can swallow capsules * Dosing is based on body weight not to exceed adult dose * Adverse events (AEs) are generally similar to those seen in adults * Information on dose, AEs, population PK analysis, lab abnormalities, and historical clinical studies Antiviral
09/19/2008 Nasacort AQ triamcinolone Treatment of the nasal symptoms of seasonal and perennial allergic rhinitis in adults and children 2 years of age and older * Expands pediatric use, or age range, to include patients 2 to 5 years of age * Dosing and administration information provided * Not recommended for children under 2 years of age * An effect on adrenal function in children 2 to 5 years of age cannot be ruled out * Pharmacokinetics were evaluated in children 2 to 5 years of age * Safety and efficacy were evaluated in one clinical study involving pediatric patients 2 to 5 years old * Studies in children >6 months and less than 2 years of age were not performed due to safety concerns since controlled clinical studies have shown that intranasal corticosteroids may cause a reduction in growth velocity in pediatric patients. Anti-inflammatory, topical
09/19/2008 Retrovir syrup, capsules and tablets zidovudine Used in combination with 18 other antiretroviral agents for the treatment of HIV-1 infection * Dosing and administration information provided to children 6 weeks to less than 18 years of age * Macrocytosis was reported in the majority of pediatric patients receiving Retrovir 180 mg/m2 every 6 hours in open-label studies * New dosing regimen Antiviral
09/12/2008 GARDASIL Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant* Prevention of vulvar and vaginal cancer caused by HPV types 16 and 18 See Package Insert for new information on biologics Preventive Vaccine
09/03/2008 Valtrex valacyclovir Chickenpox; active or at risk for herpes virus infection * New indication for treatment of chickenpox in pediatric patients 2 to <18 years based on single-dose pharmacokinetic and multiple-dose safety data from an open-label trial with valacyclovir and supported by safety and extrapolated efficacy data from 3 randomized, double-blind, placebo-controlled trials evaluating oral acyclovir in pediatric patients with chickenpox * The efficacy and safety of valacyclovir have not been established in pediatric patients: o <12 years of age with cold sores o <18 years of age with genital herpes o <18 years of age with herpes zoster o <2 years of age with chickenpox, o for suppressive therapy following neonatal HSV infection * Adverse events similar to that of adults * Information on PK parameters, AEs, clinical studies, and preparation of an extemporaneous formulation Antiviral
08/28/2008 Zemuron rocuronium Adjunct to general anesthesia * Expanded pediatric indication to include 0-17 years. Previously approved in ages 3 months  14 years * Not recommended for rapid sequence intubation in pediatric patients * In clinical studies of rocuronium, onset time and clinical duration varied with dose, the age of the patient, and anesthetic technique * The overall analysis of ECG data in pediatric patients indicates that the concomitant use of rocuronium with general anesthetic agents can prolong the QTc interval * The time to maximum block for an intubating dose was shortest in infants and longest in neonates. The duration of clinical relaxation following an intubating dose is shortest in children > 2 years to 11 years and longest in infants * Additional information on dose, clinical studies, and PK/PD parameters Anesthetic agent
08/14/2008 Zyprexa olanzapine schizophrenia; bipolar disorder * Safety and effectiveness have not been established for patients less than 18 years of age * In an analysis of placebo-controlled olanzapine monotherapy studies of adolescent patients, including those with schizophrenia or bipolar disorder, olanzapine was associated with: o Hyperglycemia - a statistically significantly greater mean change in fasting glucose levels compared to placebo o Hyperlipidemia  statistically significant increases compared to placebo in fasting triglycerides, fasting total cholesterol and fasting LDL cholesterol o Weight gain  olanzapine treated patients gained an average of 4.6 kg, compared to an average of 0.3 kg in placebo-treated patients with a median exposure of 3 weeks; Average weight gain during long-term therapy was 7.4 kg Antipsychotic
07/29/2008 Cancidas caspofungin Empirical therapy for presumed fungal infections in febrile, neutropenic patients; Candidemia and certain Candida infections; Esophageal Candidiasis; Invasive Aspergillosis in patients who are refractory to or intolerant of other therapies * Extended indication from adults to children 3 months and older based upon evidence from adequate and well-controlled studies in adults and PK data in pediatric patients and additional data from pediatric studies * The efficacy and safety have not been adequately studied in infants < 3 months * The ability of caspofungin to penetrate the blood-brain barrier and to treat patients with meningitis and endocarditis is unknown * Dosing should be based on the patients body surface area. Maximum loading dose and daily maintenance dose should not exceed 70 mg * The safety profile in pediatrics is comparably to adults * Information on dose, Aes, PK parameters, clinical studies and infusion preparation instructions Antifungal
07/24/2008 Navstel Intraocular Irrigating Solution Sterile balanced salt ophthalmic solution with hypromellose, dextrose and glutathione Use as an intraocular irrigating solution during surgical procedures involving perfusion of the eye * Safety and efficacy have been demonstrated in pediatric patients * New active ingredient Ophthalmologic flush
07/01/2008 Flovent HFA fluticasone propionate Asthma in < 4 years * Flovent HFA should be administered by the orally inhaled route only in patients 4 years and older. * Clinical studies were conducted in children with asthma 6 months to less than 4 years * Information added to Pediatric Use Antiasthmatic
06/30/2008 Aciphex rabeprazole Gastroesophageal reflux in adolescent patients 12 years of age and above * Use in adolescent patients 12 years of age and older is supported by extrapolation of results from studies in adults and safety and PK studies performed in adolescent patients * Safety and effectiveness for GERD have not been established for pediatric patients <12 years of age * Safety and effectiveness for other uses have not been established in pediatric patients * Adverse events (Aes) similar to those seen in adults * Information on dose, Aes, clinical studies Antiulcerative
06/24/2008 KINRIX Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine* Active immunization against diphtheria, tetanus, pertussis, & poliomyelitis as the fifth dose in the diphtheria, tetanus, and acellular pertussis (DTaP) vaccine series and the fourth dose in the inactivated poliovirus vaccine (IPV) series when previous DTaP vaccine doses have been with INFANRIX and/or PEDIARIX and for the first three doses and INFANRIX for the fourth dose See Package Insert for new information on biologics Preventive Vaccine
06/24/2008 Viramune Tablets 200 mg Viramune Oral Suspension 10 mg/mL nevirapine Use in combination with other antiretroviral agents for the treatment of HIV-1 infection * Dosing information provided for children ages >15 days to <16 years old * Safety was evaluated in children 2 weeks and older in 5 clinical trials and important adverse events (all causality) include rash (21%), neutropenia (8.9%), anemia (7.3%) and hepatotoxicity (2.4%) * Safety, pharmacokinetics, and virologic and immunologic responses have been evaluated in HIV-infected pediatric patients age 3 months to 18 years * Safety and pharmacokinetics were evaluated in HIV-infected pediatric patients age 15 days to < 3 months * Efficacy was evaluated in one clinical study with children 3 months to 16 years of age * Post-marketing surveillance has shown anemia to be more commonly observed in children although development of anemia due to concomitant medication use cannot be ruled out * Potential drug interaction information is provided for children with respect to lopinavir/ritonavir * New dosing regimen Antiviral
06/23/2008 Aptivus tipranavir Co-administered with ritonavir for combination antiretroviral in patients who are treatment-experienced and infected with HIV-1 strains resistant to more than one protease inhibitor * Extended indication from adults to children 2 years and older * The risk-benefit has not been established in patients <2 years of age * Dosing is based on body weight or body surface area not to exceed adult dose * Aes are generally similar to those seen in adults however, rash was more frequent in pediatric patients than in adults; The frequency of rash through 48 weeks of treatment was 21%. Most rashes were mild and 5% were moderate. Overall 3% interrupted treatment due to rash * Information on dose, Aes, PK parameters, lab abnormalities, and clinical study Antiviral
06/20/2008 Kaletra lopinavir/ ritonavir Use in combination with other antiretroviral agents for HIV-1 infection * Extended indication from 6 months  12 years to 14 days  18 years * The safety, efficacy, and pharmacokinetic profiles in pediatric patients < 14 days have not been established * Dose should be calculated based on body weight or body surface area not to exceed adult dose * Because no data exists for dosage when administered with efavirenz, nevirapine, (fos)amprenavir, or nelfinavir, it is recommended that lopinavir/ ritonavir not be administered in combination with these drugs in patients < 6 months of age * Infants <6 months of age generally had lower lopinavir AUC12 than children 6 months  12 years of age * Information on dose, PK parameters, clinical studies, and AEs Antiviral
06/20/2008 Pentacel Diphtheria And Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus B Conjugate (Tetanus Toxoid Conjugate) Vaccine* Active immunization against diphtheria, tetanus, pertussis, poliomyelitis and invasive disease due to Haemophilus influenzae type b See Package Insert for new information on biologics Preventive Vaccine
06/05/2008 Zetia and Vytorin ezetimibe and ezetimibe/ simvastatin Heterozygous familial hypercholesterolemia as an adjunct to diet * The effects of ezetimibe co-administered with simvastatin compared to simvastatin monotherapy have been evaluated in adolescent boys and girls with heterozygous familial hypercholesterolemia (HeFH) Antilipemic
05/09/2008 OraVerse Injection 0.4 mg (0.235 mg/mL) phentolamine mesylate Reversal of soft-tissue anesthesia, i.e., anesthesia of the lip and tongue, and the associated functional deficits resulting from an intraoral submucosal injection of a local anesthetic containing a vasoconstrictor * Use in children less than 6 years of age or weighing less than 15 kg (33 lbs) is not recommended * Dosing information provided for children weighing 15 to 30 kg (66 lbs) * Safety and efficacy were established in 2 clinical trials in children 12 to 17 years old, one trial in children ages 6 to 11 years, as well as adult studies * Safety has been evaluated in pediatric patients under the age of 6 years but not efficacy * Pharmacokinetics have been evaluated in children weighing 15 kg or more * New indication Anesthetic, topical
05/08/2008 Desmopressin acetate Tablets, 0.1 mg and 0.2 mg desmopressin acetate Determine the capacity of the kidney to concentrate urine in pediatric patients (Renal Concentration Capacity Test or RCCT) and management of primary nocturnal enuresis (PNE) * Efficacy in RCCT was evaluated in a single trial with children 3 to 18 years old * Three studies evaluated efficacy in children 5 to 17 years old with PNE; an additional study evaluated efficacy in adolescents 12 to 17 years old * Fluid intake should be adjusted downward in children to decrease the potential occurrence of water intoxication and hyponatremia * Dosing information provided for children 3 to 18 years old for RCCT * Dosing information provided for pediatric patients 6 years of age and older with PNE * Tablet dosage and administration information provided for children with central diabetes insipidus * Pharmacokinetics and pharmacodynamics were evaluated in children * New indications and dosing regimen Urology
05/05/2008 Argatroban argatroban Heparin-Induced Thrombocytopenia (HIT) or HIT with Thrombosis * Safety and effectiveness, including the appropriate anticoagulation goals and duration of therapy, have not been established in pediatric patients * Population PK/PD analysis of sparse data in 15 seriously ill pediatric patients ages <6 months  16 years diagnosed with HIT or suspected HIT requiring an alternative to heparin anticoagulation showed clearance in pediatric patients was 50% lower compared to healthy adults and led to dose recommendations * Information on dose, AEs and PK Hematology/Coagulation
05/05/2008 Levaquin Tablets, 250 mg, 500 mg, and 750 mg Levaquin Oral Solution, 25 mg/mL Levaquin Injection and Levaquin Injection, 5 mg/mL levofloxacin levofloxacin in 5% dextrose injection Reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis (inhalational anthrax post-exposure) * New indication * Dosing information provided for children less than and greater than 50 kg * Efficacy is based on plasma concentrations achieved in humans, a surrogate endpoint reasonably likely to predict clinical benefit, and animal studies were used to evaluate survival; the product has not been tested in humans for the post-exposure prevention of inhalation anthrax * Safety in pediatric patients treated for more than 14 days has not been studied * Long-term safety data, including effects on cartilage, following administration in pediatric patients is limited * Due to possible side effects, use is not recommended for pediatric patients except in the prevention of anthrax after inhalational exposure * Pharmacokinetics were investigated in pediatric patients 6 months to 16 years old Antibiotic
04/30/2008 Cardiolite technetium tc99m sestamibi Medical imaging in Kawasaki disease * Safety and effectiveness have not been established in the pediatric population * No evidence of diagnostic efficacy or clinical utility of scan was found in 3 clinical studies of children and adolescents with Kawasaki disease * A study of 445 pediatric patients failed to demonstrate the predictive value of Cardiolite rest and stress myocardial perfusion imaging to define children with Kawasaki disease at risk of developing cardiac events 6 months after receiving Cardiolite; only 3cardiac events were observed. In all 3 cases, the scan was negative * Adverse events similar to that of adults * Information on dose, PK, and clinical studies Diagnostic aid
04/15/2008 Patanase Nasal Spray olopatadine hydrochloride Relief of symptoms of seasonal allergic rhinitis (SAR) in patients 12 years of age and older * Safety and effectiveness in children below the age of 12 years have not been established * Symptoms of antihistamine overdose in children may initially include agitation and restlessness followed by drowsiness * Efficacy and safety were evaluated in 3 clinical trials of 2 weeks duration in adult and adolescent patients, 12 years of age and older, with symptoms of SAR * Dosage and administration information provided for children 12 years and older * New indication, dosage form, dosing regimen, and route of administration Antihistamine
04/07/2008 Orencia abatacept Moderate to severe polyarticular juvenile idiopathic arthritis * Indicated for reducing signs and symptoms in pediatric patients with moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) ages 6 years and older. * The safety and effectiveness in pediatric patients < 6 years of age and in pediatric patients for uses other than JIA have not been established * Abatacept was studied in 190 patients 6 - 17 years with polyarticular JIA. * AEs were generally similar to those seen in adults. Overall frequency of adverse events in the 4-month, lead-in, open-label period of the study was 70%; infections occurred at a frequency of 36%. A total of 6 serious adverse events were reported during the initial 4 months of treatment with abatacept. * Information on dosing, PK, immunogenicity, immunization needs, AEs, and clinical study * New indication Anti-inflammatory
04/03/2008 ROTARIX Rotavirus Vaccine, Live, Oral* Prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9) See Package Insert for new information on biologics Preventive Vaccine
03/31/2008 Lancôme UV Expert 40 La Roche-Posay Anthelios 40 Vichy Capital Soleil 40 avobenzone, ecamsule, octocrylene, titanium dioxide cream Sunscreen OTC * Effectiveness extrapolated from adult studies * Safety studies included pediatric patients 6 months of age and older * Age range based on standards established in over-the counter monograph for sunscreens * New active ingredient * Sunscreen
03/26/2008 Ventolin HFA albuterol Treatment of symptoms of bronchospasm associated with obstructive airway disease * Safety and effectiveness of albuterol administered with or without a spacer device in children < 4 years of age has not been demonstrated * 3 randomized, double-blind, placebo-controlled studies in 250 children < 4 years, in which efficacy was not demonstrated, suggest that either the optimal dose has not been defined in this age-group or the drug is not effective in this age-group * Information on clinical studies Antiasthmatic
03/25/2008 Reyataz atazanavir HIV in 6 years and older * Extended indication from adults to children 6 years and older * The safety, activity, and pharmacokinetic profiles in pediatric patients ages 3 months to < 6 years have not been established. Atazanavir should not be administered to pediatric patients below the age of 3 months due to the risk of kernicterus * Dosing is based on body weight or body surface area not to exceed adult dose * Adverse events (AEs) are generally similar to those seen in adults * Information on dose, AEs, PK parameters, lab abnormalities, and clinical study Antiviral
03/24/2008 Depakote ER Depakote Sprinkles divalproex disodium Pediatric Bipolar Disorder; Prophylaxis of Migraine * Efficacy was not established in a double-blind, placebo controlled study of patients 10-17 years conducted to evaluate efficacy in the treatment of pediatric bipolar disorder * Efficacy was not established in a double-blind, placebo-controlled study of patients 12  17 years conducted to evaluate the efficacy in the prophylaxis of migraine * The safety and tolerability was similar to adults in 5 long-term safety studies * Additional information on clinical studies, AE profile in Depakote ER labeling Anticonvulsant; Mood Stablizer
03/20/2008 Prilosec omeprazole Maintenance healing of erosive esophagitis * Efficacy was extrapolated from adults and older children to 1 to 2 year olds and supported with an open-label trial * Unique adverse reactions in pediatric patients included increased respiratory system adverse events and fever. * Safety and effectiveness in children less than 1 year of age have not been established * Dosing and administration information provided for patients 1 year and older weighing at least 5 kg. * New dosage form Antiulcerative
03/20/2008 Zometa zoledronic acid Severe osteogenesis imperfecta * Zoledronic acid is not indicated for use in children * Safety and effectiveness was studied in 152 pediatric patients with severe osteogenesis imperfecta aged 1 - 17 years. At one year, increases in BMD were observed in the zoledronic acid treatment group but the changes did not necessarily correlate with the risk for fracture or the incidence or severity of chronic bone pain * Information on PK, clinical study, and AE profile Bone density
03/19/2008 ARTISS Fibrin Sealant (Human)* To adhere autologous skin grafts to surgically prepared wound beds resulting from burns See Package Insert for new information on biologics Wound healing
03/14/2008 NovoLog insulin aspart [rDNA origin] injection Insulin analog indicated to improve glycemic control * Efficacy was demonstrated in a clinical study with pediatric patients ages 4 to 18 years using an external insulin pump * New dosing regimen Antidiabetic
03/12/2008 DAPTACEL Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed* Active immunization as a booster dose against diphtheria, tetanus & pertussis See Package Insert for new information on biologics Preventive Vaccine
02/27/2008 Abilify aripiprazole Bipolar I Disorder * Extended treatment of acute Bipolar Disorder indication from adults to pediatrics 1017 years * The efficacy for the maintenance treatment of Bipolar Disorder in the pediatric population has not been evaluated * The recommended target dose in Bipolar Disorder is 10 mg/day. * In the study of pediatric patients 10  17 years with Bipolar Mania, 4 common adverse reactions had a possible dose response relationship at 4 weeks; extrapyramidal disorder, somnolence, akathisia and salivary hypersecretion * Information on dose, AEs, clinical studies Antipsychotic
02/27/2008 Nexium esomeprazole Short-term treatment of GERD * Expanded age range to include pediatric patients 1-11 years. Previously approved in 12-17 years * Use in pediatric patients 1 to 17 years of age is supported by extrapolation from studies in adults, and safety and PK studies performed in pediatric and adolescent patients * Safety and effectiveness in pediatric patients <1 year of age have not been established * Safety and effectiveness for other pediatric uses have not been established * Information on dose, treatment related adverse events (AEs), clinical study * New formulation Antiulcerative
02/21/2008 Humira adalimumab Treatment of juvenile idiopathic arthritis * Indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (JIA)in patients 4 years of age and older * Has not been studied in children <4 years of age; there are limited data on treatment in children with weight <15 kg * Safety and efficacy in pediatric patients for uses other than JIA have not been established * Adalimumab was studied in 171 patients 4 - 17 years with polyarticular JIA. * AEs were generally similar to those seen in adults. 45% of children experienced an infection while receiving adalimumab with or without concomitant MTX in the first 16 weeks of treatment. Serious infections were observed in 4% of patients within approximately 2 years of initiation of treatment * Information on dose, AEs, lab abnormalities, PK parameters, immunogenicity, immunization needs and clinical study * New indication Anti-inflammatory
02/01/2008 Asmanex Twisthaler 110mcg inhalation powder mometasone furoate Maintenance treatment of asthma as prophylactic therapy in children 4 years of age and older * Not indicated for relief of acute bronchospasm or in children less than 4 years of age * Clinical studies, including 52 week safety trial conducted in children 4  11 years of age * Pediatric dosing information provided * Child may not get the most benefit for 1 to 2 weeks or longer after starting treatment * New dosage form Antiasthmatic
01/31/2008 Inspra eplerenone Hypertension * Effectiveness was not established in a study of 304 hypertensive pediatric patients 4 - 17 years; eplerenone, at doses up to 100 mg/ day, did not lower blood pressure effectively * Therefore, it has not been studied in hypertensive patients <4 years old * Eplerenone has not been studied in hypertensive patients < 4 years or in pediatric patients with heart failure * Adverse events similar to that of adults Antihypertensive
01/28/2008 Xyzal 0.5 mg/mL Oral Solution levocetirizine dihydrochloride Relief of symptoms associated with seasonal and perennial allergic rhinitis (SAR and PAR) and treatment of uncomplicated skin manifestations of chronic idiopathic urticaria (CIU) * Dosing information provided * Studies waived in children less than 6 months of age with PAR and CIU * Waived in children less than 2 years of age with SAR * New dosage form pediatric Antihistamine
01/23/2008 Moxatag amoxicillin Use for tonsillitis and/or pharyngitis secondary to Streptococcus pyogenes patients 12 years of age and older * Safety and effectiveness in pediatric patients younger than 12 years have not been established * One clinical study evaluated safety and effectiveness in pediatric patients 12 years of age and older with no significant differences in treatment response or adverse reactions between adults and children * A prospective study of 51 children suggested that overdosages of less than 250 mg/kg are not associated with significant clinical symptoms and do not require gastric emptying * Waiver of studies in children ages 0 to less than two years because too few children have the disease * New dosage form Antibiotic
01/17/2008 TamiFlu oseltamivir Safety information resulting from studies that established treatment of uncomplicated acute illness due to influenza infection in patients 1 year and older * Influenza can be associated with a variety of neurologic and behavioral symptoms which can include events such as hallucinations, delirium, and abnormal behavior, in some cases resulting in fatal outcomes. These events may occur in the setting of encephalitis or encephalopathy but can occur without obvious severe disease. * These events have been reported in patients receiving oseltamivir, primarily among pediatric patients, appear to be uncommon, and often had an abrupt onset and rapid resolution * If neuropsychiatric symptoms occur, the risks and benefits of continuing treatment should be evaluated for each patient Antiviral
01/10/2008 Alvesco Inhalation Aerosol, 80 mcg & 160 mcg ciclesonide Treatment of asthma in patients 12 years of age and older. * Not indicated for children under the age of 12 years * Five clinical studies evaluated safety in children 12 years of age and older * Safety and effectiveness have not been established in children under 12 years of age * Waiver of studies in children 0 to less than 6 months of age due to too few patients with the disease * New dosage form Antiasthmatic
01/02/2008 EVICEL Fibrin Sealant (Human)* Adjunct to hemostasis for use in patients undergoing surgery, when control of bleeding by standard surgical techniques is ineffective or impractical See Package Insert for new information on biologics Coagulant
12/27/2007 AndroGel testosterone Use in adolescent boys with delayed puberty * Safety and efficacy in males < 18 years old have not been established * Improper use may result in acceleration of bone age and premature closure of epiphyses Androgen-anabolic steroid
12/27/2007 Voluven 6% Hydroxyethyl Starch 130/0.4 In 0.9% Sodium Chloride Injection* Plasma volume substitute for treatment and prophylaxis of hypovolemia See Package Insert for new information on biologics Coagulant
12/19/2007 Hepsera adefovir dipivoxil Chronic hepatitis B virus infection * Extended indication from adults to pediatric patients 12 years and older * Not recommended for children <12 years of age. Efficacy was not significantly different from placebo in a clinical study in children <12 years * Safety e12  < 18 years was similar to that observed in adults * Information on PK, AEs, clinical study, clinical resistance Antiviral
12/12/2007 Derma-Smoothe/FS Topical Oil fluocinolone Treatment of atopic dermatitis in pediatric patients 3 months and older for up to 4 weeks * Extended age range down to 3 months * Effectiveness and safety are not established in children less than 3 months old * Safety was evaluated in two pediatric clinical studies (including facial use) * Pediatric dosing and administration information provided * Studies waived in children under 3 months of age due to safety concerns of adrenal suppression * New indication Anti-inflammatory, topical
11/29/2007 Triesence 40mg/mL triamcinolone acetonide injectable suspension Visualization during vitrectomy * Efficacy and safety of corticosteroids in the pediatric population are based on the well-established course of effect of corticosteroids, which is similar in pediatric and adult populations * Adverse effects of corticosteroids in pediatric patients are similar to those in adults * New indication Anti-inflammatory, topical
11/29/2007 Diovan valsartan Hypertension * Labeling for 6-16 years of age * Not recommended for pediatric patients less than 6 years due to safety findings possibly related to treatment or with glomerular filtration rate < 30mL/min/1.73m2 * Information on dose, clinical studies in 1-16 years and pharmacokinetics * No relevant differences were identified between adverse experience profile for pediatric patients and that previously reported for adult patients * Information on preparation of a suspension Antihypertensive
11/21/2007 Omnaris Nasal Spray ciclesonide Treatment of seasonal allergic rhinitis (SAR) in patients 6 through less than 12 years of age * Indication extended down to 6 years of age * Pediatric dosing information provided * Two clinical studies evaluated safety in children 6 to 11 years of age and the overall incidence of adverse events was comparable to those treated with placebo * Efficacy in children 2 to 5 years of age was not established in clinical trials conducted in this age group. * Waiver of studies in children ages 0 to less than 2 years of age for SAR because of local and systemic safety concerns as well as lack of disease and/or diagnosis difficulties in children * New indication Antiasthmatic; antiallergy
11/09/2007 Kaletra Oral Solution, 80 mg/20 mg & Kaletra (1opinavir/ritonavir) Tablets, 200 mg/50 mg lopinavir/ ritonavir HIV -1 protease inibitor indicated in combination with other antiretroviral agents for the treatment of HIV -1 infection. * Dosing and administration information provided for children * Use of a lower strength tablet in a twice daily dosing regimen for pediatric patients weighing greater than 15 kg * New dosing regimen Antiviral
10/30/2007 Combigan 0.2%/0.5% ophthalmic solution brimonidine tartrate/timolol maleate Reduction of elevated intraocular pressure in patients with glaucoma or ocular hypertension * Safety and effectiveness supported by evidence from clinical studies in adults with additional data from a study in children with glaucoma ages 2  7 years old * Not recommended for use in children under the age of 2 years due to safety concerns based on reports of apnea, bradycardia, hypotension, hypothermia, hypotonia, and somnolence in infants * Safety and effectiveness have not been studied in children below the age of two years * New active ingredient Ophthalmologic hypotensive
10/29/2007 Abilify aripiprazole Schizophrenia * Extended schizophrenia indication from adults to adolescents 1317 years * Safety and effectiveness in pediatric patients with bipolar mania or agitation associated with schizophrenia or bipolar mania have not been established * Efficacy for the maintenance treatment of schizophrenia in the pediatric population has not been evaluated * In 6-week placebo controlled efficacy trial in patients 13  17 years with Schizophrenia 30 mg/day was not shown to be more efficacious than 10 mg/day * Common adverse events observed were extrapyramidal disorder, somnolence, and tremor; these 3 AEs appear to have a possible dose response relationship * Information on dose, AEs, clinical studies Antipsychotic
09/28/2007 Lamisil Oral Granules terbinafine Tinea capitis * New indication in 4 years and older * Two randomized safety and efficacy trials were conducted in patients 4 to 12 years old with tinea capitis. Terbinafine was dosed on a mg/kg basis and treated for 6 weeks * Although no hepatotoxicity was seen during trials, pre-treatment serum transaminases tests are advised. * The most common adverse events observed in the trials were nasopharyngitis, headache, pyrexia, cough, vomiting, and upper respiratory tract infection * New 125 mg and 187.5 mg oral granule formulations developed; take with food * Information on dose, PK parameters, AE profile, and instructions for use Antifungal, topical
09/20/2007 Norditropin Cartridges somatropin (rDNA origin) Treatment of short stature in children with Turner syndrome * Safety and effectiveness based on studies in pediatric patients * New Warning: Patients with Turner syndrome should be evaluated carefully for otitis media and other ear disorders since these patients have an increased risk of ear and hearing disorders. Somatropin treatment may increase the occurrence of otitis media in patients with Turner syndrome. In addition, patients with Turner syndrome should be monitored closely for cardiovascular disorders (e.g., stroke, aortic aneurysm/dissection, hypertension) as these patients are also at risk for these conditions * Information on recommended dosing, adverse events (AEs) and clinical studies * New indication Growth hormone
09/11/2007 Levaquin levofloxacin Community-acquired pneumonia * Levofloxacin is not indicated for pediatric patients < 18 years of age * In a prospective, long-term, surveillance study, levofloxacin treated children had a significantly higher incidence of musculoskeletal (MS) disorders (arthralgia, arthritis, tendonopathy, and gait abnormality) compared to non-fluoroquinolone-treated children * Information on clinical studies, AE profile Antibiotic
08/22/2007 Risperdal risperidone Schizophrenia; short-term treatment of acute manic or mixed Episodes associated with Bipolar I Disorder * Extended schizophrenia indication from adults to adolescents 1317 years; extended bipolar mania indication from adults to children and adolescents 10-17 years * Safety and effectiveness in children < 13 years of age with schizophrenia have not been established; safety and effectiveness in children < 10 years of age with bipolar mania have not been established * No additional benefit was seen above 3 mg/day in schizophrenia studies and 2.5 mg/day in the Bipolar mania study; higher doses were associated with more adverse events. Doses higher than 6 mg/day have not been studied. * Information on dose, clinical studies, AE profile Antipsychotic
08/17/2007 Provigil modafinil Narcolepsy * Modafinil is not approved for use in pediatric patients for any indication * Safety and effectiveness were not demonstrated in a controlled 6-week study in 165 pediatric patients 5-17 years with narcolepsy * Serious rash, including Stevens-Johnson Syndrome, requiring hospitalization and discontinuation of treatment has been reported in adults and children in association with the use of modafinil * In the controlled and open-label clinical studies, treatment emergent adverse events of the psychiatric and nervous system included Tourettes syndrome, insomnia, hostility, increased cataplexy, increased hypnagogic hallucinations and suicidal ideation * Information on safety, AEs and clinical study CNS Stimulant
08/16/2007 Zingo lidocaine Topical local analgesia prior to venipuncture or peripheral intravenous cannulation in children 3-18 years of age *Su mmary is pending Anesthetic, topical
07/18/2007 Toprol XL metoprolol Hypertension * A study in 144 pediatric hypertensive pediatric patients aged 6 - 16 years did not meet its primary endpoint. However, some study endpoints demonstrated effectiveness * Adverse event profile similar to adults * Safety and effectiveness have not been established in patients < 6 years of age * Information on PK parameters, clinical studies, and dose Antihypertensive
06/14/2007 Lexiva Oral Suspension fosamprenavir Treatment of HIV infection in patients 2-18 years of age * Effectiveness and safety were established in two clinical studies of pediatric patients 2-18 years of age * Adverse event profile is similar to that of adults with the exception of vomiting, which, regardless of causality, occurred more frequently among pediatric patients * Dosing information provided * Studies waived in children 0-1 month of age and deferred in children 1 month - 2 years of age * New dosage form Antiviral
06/12/2007 Extina Foam, 2% ketoconazole Topical treatment of seborrheic dermatitis in immunocompetent patients 12 years of age and older * Effectiveness and safety were established in a clinical study that included 44 patients from 12-17 years of age * Studies waived in children 0-12 years of age * New dosage form Antifungal, topical
06/08/2007 Betoptic S betaxolol Elevated intraocular pressure in patients with chronic open-angle glaucoma or ocular hypertension * Extended indication from adults to pediatric patients * The adverse reaction profile was comparable to that seen in adults Ophthalmologic hypotensive
06/08/2007 Timolol GFS timolol Elevated intraocular pressure in patients with chronic open-angle glaucoma or ocular hypertension * Extended indication from adults to pediatric patients * The adverse reaction profile was comparable to that seen in adults Ophthalmologic hypotensive
05/30/2007 Zyflo CR Extended Release Tablets zileuton Prevention and chronic treatment of asthma in children 12 years of age and older * Should not be used in children under 12 years of age * Effectiveness was established in clinical studies that included pediatric patients 12 years of age and older * Short-term and long-term safety were established in clinical studies that included pediatric patients 12 years of age and older * Studies waived in children 0-4 years of age and deferred in children 5-11 years of age * New dosage form Antiasthmatic
05/25/2007 Xyzal Tablets 5 mg levocetirizine Relief of symptoms associated with seasonal allergic rhinitis and perennial allergic rhinitis in adults and children 6 years of age or older, and for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 years of age or older *Su mmary is pending Antihistamine
05/18/2007 Locoid Lotion 0.1% hydrocortisone butyrate Treatment of mild to moderate atopic dermatitis in children 3 months of age and older * Effectiveness established in one study of 284 patients from 3 months to 18 years of age * Information provided on HPA axis suppression from one safety study with Locoid Lotion of 84 pediatric patients from 3 months to 18 years of age with moderate to severe atopic dermatitis affecting at least 25% of body surface area * Studies waived in children < 3 months of age * New dosage form Anti-inflammatory, topical
04/27/2007 Azasite Ophthalmic Solution 1% azithromycin Treatment of bacterial conjunctivitis caused by certain microorganisms in patients down to 1 year of age * Effectiveness and safety were established in controlled clinical trials including patients down to 1 years of age * Dosing information provided * New dosage form Antibiotic
04/27/2007 Veramyst fluticasone furoate Treatment of the symptoms of seasonal and perennial allergic rhinitis *Approved in patients 2 years and older * Controlled clinical trials included 1,224 patients 2 - 11 years and 344 adolescent patients 12 to 17 years* The safety and effectiveness in children < 2 years have not been established* Information on clinical trials, dosing, and adverse reactions*New drug Anti-inflammatory, topical
04/19/2007 Valtropin somatropin (rDNA origin) Short stature in children with Turner Syndrome *Su mmary is pending Growth hormone
04/12/2007 Altabax Ointment 1% retapamulin Treatment of impetigo in patients 9 months of age and older * Safety and effectiveness established in studies that included 588 pediatric patients from 9 months of age to 17 years of age * Studies waived in children 0-2 months of age and deferred in children 2-9 months of age * New active ingredient Antibiotic, topical
03/28/2007 Ambien zolpidem Insomnia associated with ADHD * Safety and effectiveness have not been established in pediatric patients with insomnia associated with ADHD * In an 8-week controlled study in 201 pediatric patients 6-17 years, psychiatric and nervous system disorders comprised > 5% of treatment emergent adverse events, including dizziness (23.5%) headache (12.5%) and hallucinations (7.4%); treatment was discontinued due to an adverse event in 7.4% Hypnotic
03/22/2007 Aldara imiquimod Molluscum contagiosum * Efficacy in patients 2  12 years for the treatment of molluscum contagiosum was not demonstrated in two clinical trials in 702 patients * Information on clinical studies and AEs Topical
03/19/2007 Keppra Tablets/ Keppra Oral Solution levetiracetam Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in children 6 years of age and older with idiopathic generalized epilepsy * Safety and effectiveness established in study that included patients down to 4 years of age * Pediatric dosing information added * Studies waived in children 1 month to 2 years of age and deferred in children 2-6 years of age * New indication Anticonvulsant
02/23/2007 Coreg carvedilol Heart failure * Effectiveness has not been established in patients < 18 years * In a double-blind trial of 161 children, 2 months to 17 years with chronic heart failure receiving standard background treatment, randomized to placebo or carvedilol, carvedilol demonstrated reduction of heart rate 4-6 beats per minute * There was no significant effect of treatment on clinical outcomes after 8 months of follow-up * AEs occurring in e 10% of patients treated with carvedilol included chest pain (17%), dizziness (13%), and dyspnea (11%) Antihypertensive
02/23/2007 Vyvanse Capsules lisdexamfetamine Treatment of ADHD in children 6 to 12 years of age * Effectiveness established in two studies of patients 6-12 years of age * Long-term effectiveness of more than 4 weeks has not been established * Studies waived in children 0-5 years of age and deferred in children 13-17 years of age * New active ingredient CNS Stimulant
02/07/2007 Actiq fentanyl Treatment of breakthrough pain in opioid tolerant children * Safety and efficacy in patients below the age of 16 years was not established in a clinical trial of 15 patients 5 to 15 years * Information on PK parameters and clinical studies Anesthetic agent
01/10/2007 Eloxatin oxaliplatin Solid tumors * The effectiveness of oxaliplatin in children has not been established * No significant activity observed in 2 Phase I and 2 Phase II trials in 159 patients ages 7 months to 22 years with solid tumors * Information on clinical studies and AEs Antineoplastic
12/22/2006 Emtriva emtricitabine HIV-1 infection in combination with other antiretroviral agents * Efficacy in preventing or treating HIV in neonates to 3 month olds could not be determined after a PK study in 20 neonates born to HIV positive mothers * Information on dose in 0-3 months, additional safety and PK parameters Antiviral
12/20/2006 Colazal balsalazide Mildly to moderately active ulcerative colitis in patients 5 years of age and older * Extended indication from adults to patients 5 years and older * Dosing can be initiated at either 6.75 or 2.25 g/day * PK of balsalazide, and metabolites showed very large inter-patient variability similar to that seen in adults * AEs were similar to those seen in adults Gastroenterology
12/15/2006 Celebrex celecoxib Relief of the signs and symptoms of juvenile rheumatoid arthritis (JRA) * New indication in 2 years and older * Has not been studied in patients < 2 years, in patients with body weight < 10 kg, or in patients with active systemic features * Celecoxib should be used only with caution in patients with systemic onset JRA due to the risk for serious adverse reactions including the risk of disseminated intravascular coagulation * The long-term cardiovascular toxicity in children has not been evaluated; it is unknown if the long-term risk may be similar to that seen in adults * New 50 mg capsule developed * Information on adding contents of a capsule to applesauce. for patients with difficulty swallowing capsules * Information on dose, clinical studies, PK parameters, AEs Anti-inflammatory
12/15/2006 Suprane desflurane Safety study of 2 agents used for maintenance of anesthesia in non-intubated patients * Not indicated for maintenance of anesthesia in non-intubated pediatric patients * In a clinical safety trial in patients 2 - 16 years, desflurane and isoflurane were compared for maintenance of anesthesia in non-intubated patients to assess the incidence of respiratory adverse events. Desflurane was associated with higher rates of coughing, laryngospasm and secretions with an overall rate of respiratory events of 39%. 5% of pediatric patients 2-16 years old exposed to desflurane, experienced severe laryngospasm * The incidence of respiratory events was highest in children aged 2-6 years; therefore, similar studies in children under the age of 2 years were not initiated. * Additional information on clinical studies and AEs Anesthetic agent
11/07/2006 Ziana Gel clindamycin; tretinoin Treatment of acne vulgaris in patients 12 years of age and older * Effectiveness and safety based on two studies in patients 12 years of age and older * New active ingredient Antiacne, topical
11/01/2006 Humatrope for injection somatropin (rDNA origin) Treatment of short stature or growth failure in children with short stature homeobox-containing gene (SHOX) deficiency * Effectiveness established from one 2-year study for SHOX in 52 pediatric patients * Information on adverse events provided * Dosing information provided * New indication Growth hormone
10/20/2006 Desonate Gel desonide Treatment of mild to moderate atopic dermatitis in children 3 months of age and older * Effectiveness established from two studies in patients 3 months to 18 years of age * Not recommended for use in patients under 3 months of age * Treatment should not exceed 4 consecutive weeks * HPA axis suppression studied in patients 6 months of age to 6 years of age * New dosage form Anti-inflammatory, topical
10/19/2006 Zaditor ophthalmic solution ketotifen Temporary relief of itchy eyes in children 3 years of age and older OTC * No new studies submitted * New indication Antihistamine, topical
10/16/2006 Allegra fexofenadine Seasonal allergic rhinitis (SAR) uncomplicated skin manifestations of chronic idiopathic urticaria (CIU) * New suspension developed * Suspension indicated for the treatment of SAR in 2  11 years based on the PK comparisons in adult and pediatric patients and an extrapolation of efficacy in adults; Suspension indicated for the treatment of CIU in 6 months  11 years based on the PK comparisons in adults and children and an extrapolation of efficacy in adults * Safety and effectiveness of suspension in pediatric patients under 6 months of age have not been established * Additional information on dose, PK parameters, safety and AEs Antihistamine
10/13/2006 Tirosint capsules levothyroxine Replacement or supplemental therapy in hypothyroidism; treatment or prevention of euthyroid goiters * Contraindicated in infants, small children, or any child who may be unable to swallow a capsule. * Dosing information provided * Information to monitor disease provided * No clinical studies submitted * New dosage form Thyroid replacement
10/06/2006 Risperdal Tablets Risperdal Oral Solution Risperdal M-Tabs risperidone Treatment of irritability associated with autistic disorder in children 5 years of age and older * Effectiveness and safety established based on two 8 week studies in patients 5-16 years of age and one long-term study of 4-6 months * Studies waived in children under 2 years of age due to difficulty to diagnose and treat this population * New indication Antipsychotic
10/05/2006 UV Protective Suncare Capital Soleil 20 Anthelios 20 UV Expert 20 avobenzone; ecamsule; octocrylene; titanium Prevention of sunburn and protection from UVA and UVB rays in children 6 months of age and older OTC * No clinical studies submitted to support * Age range based on monograph * Studies deferred in children under 6 months of age * New active ingredient Sunscreen
09/29/2006 Fuzeon enfuvirtide HIV-1 infection in treatment-experienced patients with evidence of HIV-1 replication despite ongoing antiretroviral therapy * Additional safety and efficacy data and AE information from clinical study in 5-16 year olds * Insufficient data to provide dosing recommendations in patients < 6 years Antiviral
09/29/2006 DuraPrep Surgical Solution iodine; isopropyl alcohol Preoperative skin preparation for use in children 2 months of age and older OTC * Effectiveness based on determination that permeability of skin in children > 2 months of age is essentially that of adult skin * Studies waived in children under 2 months of age for safety reasons and includes the following statement in the label: Do not use in children under 2 months of age due to excessive skin irritation and transient hypothyroidism. * New active ingredient Antiseptic
09/28/2006 Azopt ophthalmic suspension brinzolamide Elevated intraocular pressure * IOP-lowering efficacy was not demonstrated in a 3-month controlled clinical study in which brinzolamide was dosed only twice a day in pediatric patients 4 weeks to 5 years of age Ophthalmologic hypotensive
09/28/2006 Betaxon ophthalmic suspension levobetaxolol Elevated intraocular pressure * Extended indication from adults to pediatric patients * The adverse event profile was comparable to that seen in adults and elderly patients Ophthalmologic hypotensive
09/27/2006 Gleevec imatinib mesylate Treatment of newly diagnosed pediatric patients with Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase * Extended age range for the treatment of newly diagnosed CML down to pediatric patients * There are no data in children < 2 years of age * Follow-up in children with newly diagnosed Ph+ chronic phase CML is limited * Information on hematologic toxicities, AE profile, clinical studies and dosing guidelines new for newly diagnosed pediatric patients Antineoplastic
09/22/2006 Lamictal Tablets Lamictal Chewable Dispersible Tablets lamotrigine Adjunctive therapy for primary generalized tonic-clonic seizures in children 2 years of age and older * Effectiveness established in study with patients down to 2 years of age * Revised boxed warning to remove restrictions on use in pediatric patients * New indication Anticonvulsant
09/19/2006 Verdeso Foam desonide Treatment of mild to moderate atopic dermatitis in patients 3 months of age and older * Effectiveness established from studies in 581 pediatric patients 3 months to 17 years of age * Effect on HPA axis function was investigated in pediatric patients 6 months to 17 years of age in one study of 75 patients * Safety has not been evaluated in patients below 3 months of age * Use for the minimum amount of time necessary due to the potential to suppress HPA axis treatment should not exceed 4 consecutive weeks * New dosage form Anti-inflammatory, topical
09/15/2006 Noxafil Oral Suspension posaconazole Prevention of invasive Aspergillis and Candida infections in patients 13 years of age and older * Information on PK and safety studies in patients 13-17 years of age * Safety profile in patients 8-17 years of age similar to adults * Safety and effectiveness in patients below 13 years of age have not been established * Additional information on pharmacokinetics provided in patients down to 8 years of age * Studies deferred in children 0-12 years of age * New drug Antifungal
07/28/2006 Xolegel Gel ketoconazole Treatment of seborrheic dermatitis in children 12 years of age and older * Effectiveness established from studies in patients 12 years of age and older * Safety and effectiveness in pediatric patients below 12 years of age have not been establishedstudies waived in children 0-12 years of age * New dosage form Antifungal, topical
07/27/2006 Sodium Chloride Injection sodium chloride Use in flushing compatible contrast agents through IV administration sets into indwelling intravascular access devices * Safety of manual injection in pediatric patients is supported by reported clinical experience with IV infusion and flush safety and effectiveness of Sodium Chloride Injection, USP 0.9% administered by power injection in pediatric patients have not been established * Administration to pediatric patients by power injection is not recommended * To minimize the risk of fluid overload, the smallest dose necessary for manually flushing contrast agent through the vascular access line should be used * Manual injection to pediatric patients should take into account the patient's weight, fluid status, and concomitant medical conditions to determine if use is appropriate * New indication Hematology/Coagulation
07/21/2006 Anthelios SX Cream avobenzone; ecamsule; octocrylene Prevention of sunburn and protection from UVA and UVB rays in children 6 months of age and older OTC * Effectiveness extrapolated from adult studies * Safety studies included pediatric patients 6 months of age and older * Age range based on monograph * Deferred studies in children < 6 months of age * New active ingredient Sunscreen
07/21/2006 Symbicort Inhalation Aerosol Formoterol / budesonide Long-term maintenance treatment of asthma in children 12 years of age and older * Effectiveness and safety in patients 12 years of age and older established in studies up to 12 months long * PK studies in patients 6-11 years of age * Effectiveness in patients 6 to < 12 years of age has not been established * Overall safety profile in patients 6 to < 12 years of age was similar to that observed in patients 12 years of age and older * Studies waived in children 0-6 years of age; deferred in children 6-12 years of age * New active ingredient Antiasthmatic
06/29/2006 Lidocaine and Tetracaine Cream lidocaine; tetracaine Topical local analgesia for superficial dermatological procedures * Studies failed to show effectiveness over placebo in reducing the pain associated with venipuncture in pediatric patients 5-17 years of age * New active ingredient Anesthetic, topical
05/10/2006 Sandostatin LAR octreotide Weight loss due to hypothalamic obesity from cranial insult * A randomized double-blind, placebo-controlled study in 60 patients aged 6 17 years with hypothalamic obesity from cranial insult did not demonstrate efficacy and safety of octreotide as a weight loss agent; Mean BMI increased 0.1 kg/m2 in drug treated patients compared to 0.0 kg/m2 in control-treated patients * No unexpected AEs were observed; However, the incidence of new cholelithiasis in this pediatric population (33%) was higher than that seen in adult indications * Information on PK parameters and AEs Endocrine agent
05/08/2006 Solodyn Extended-Release Tablets minocycline Treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in children 12 years of age and older * Only used to treat inflammatory lesions of non-nodular moderate to severe acne vulgaris * Safety and effectiveness established from studies in patients 12 years of age and older * Safety and effectiveness in pediatric patients below 12 years of age has not been established * Studies waived in children 0-11 years of age * New dosage form Antibiotic
04/28/2006 Nexium esomeprazole Short-term treatment of GERD * Use in adolescent patients 12 to 17 years of age is supported by extrapolation from studies in adults, and safety and PK studies performed in adolescent patients * Safety and effectiveness in patients < 12 years has not been established * Safety and effectiveness for other pediatric uses have not been established * Information on dose, treatment related AEs, clinical study Antiulcerative
04/27/2006 Genotropin Injection somatropin (rDNA origin) Long-term treatment of growth failure associated with Turner syndrome * Indicated for use in pediatric patients with open epiphyses * Effectiveness and safety based on studies in pediatric patients * New indication Growth hormone
04/10/2006 Lescol & Lescol XL fluvastatin Heterozygous familial hypercholesterolemia as an adjunct to diet * New indication in adolescent boys and girls (at least one year post-menarche) 10-16 years of age, with heterozygous familial hypercholesterolemia * Information on dose, AE profile and clinical studies Antilipemic
04/06/2006 Daytrana methylphenidate ADHD *Su mmary is pending CNS Stimulant
03/29/2006 Relenza zanamivir Prevention of influenza in children 5 years of age and older * Safety and effectiveness for prophylaxis based on 4 clinical studies in patients 5-16 years of age * No differences in safety and effectiveness were observed between pediatric and adult subjects. * Dosing information provided * Studies waived in children <5 years of age * New indication Antiviral
03/16/2006 Avapro irbesartan Hypertension * In a study at a dose up to 4.5 mg/kg once daily, irbesartan did not appear to lower blood pressure effectively in pediatric patients ages 6 to 16 years Antihypertensive
03/02/2006 Vanos Cream fluocinonide Relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in children 12 years of age and older * Use in pediatric patients younger than 12 years of age is not recommended * Effectiveness extrapolated from adult studies * Safety in patients 12 to 17 years of age was similar to that observed in adults * Information provided on HPA axis suppression from safety studies with Vanos Cream in 4 cohorts of pediatric patients (3 months - 18 years of age) with atopic dermatitis * Studies waived in children 0-11 years of age * New indication Anti-inflammatory, topical
02/28/2006 Flovent HFA fluticasone propionate Asthma in 4 - 11 years * Flovent HFA should be administered by the orally inhaled route only in patients 4 years and older. * Clinical studies were conducted in children with asthma 6 months to less than 4 years * Information added to Pediatric Use Antiasthmatic
02/16/2006 Vusion Ointment miconazole Adjunctive treatment of diaper dermatitis in children 4 weeks of age and older * Indicated for use in immunocompetent children * Presence of candidal infection should be established by microscopic evaluation prior to initiating treatment * Effectiveness based on three clinical studies in infants and toddlers * Safety when used for more than 7 days is not known * New active ingredient Antifungal, topical
02/03/2006 ProAir HFA Inhalation Aerosol albuterol Prevention of exercise-induced bronchospasm in children 12 years of age and older * Expands use from previously approved bronchospasm with reversible obstructive airway disease * Effectiveness based on study in adults and adolescents * Safety and effectiveness in pediatric patients below 12 years of age have not been established * New indication Antiasthmatic
02/01/2006 Clarinex-D 12 Hour Extended Release Tablets desloratadine/pseudoephedrine Relief of nasal and non-nasal symptoms of seasonal allergic rhinitis in children 12 years of age and older * Approval based on two safety and effectiveness studies in patients down to 12 years of age * Not an appropriate dosage form for use in pediatric patients below 12 years of age. * Studies waived in children < 12 years of age * New dosing regimen Antihistamine
12/21/2005 Fosamax alendronate Severe osteogenesis imperfecta * Alendronate is not indicated for use in children * The efficacy and safety were examined in a randomized, double-blind, placebo-controlled two-year study of 139 patients, 4-18 years old, with severe osteogenesis imperfecta * Treatment with alendronate did not reduce the risk of fracture * There were no statistically significant differences between the alendronate and placebo groups in reduction of bone pain * Information on PK parameters, AE profile, and clinical studies Bone density
12/21/2005 TamiFlu oseltamivir Prophylaxis in pediatric patients 1 year to <13 years of age * Information on postmarketing clinical study in patients 1 to 12 years Antiviral
12/08/2005 Meridia sibutramine Obesity * The data are inadequate to recommend the use of sibutramine for the treatment of obesity in pediatric patients * Efficacy in obese adolescents has not been adequately studied * Sibutramine's mechanism of action inhibiting the reuptake of serotonin and norepinephrine is similar to that of some antidepressants * It is unknown if sibutramine increases the risk of suicidal behavior or thinking in pediatric patients * In a study of adolescents with obesity in which 368 patients were treated with sibutramine and 130 patients with placebo, one patient in each group attempted suicide. Suicidal ideation was reported by 2 sibutramine-treated patients and none of the placebo patients Obesity management
12/01/2005 Effexor XR Extended-Release Capsules venlafaxine Social anxiety disorder * Provided additional safety data for changes in weight, height, and appetite occurring in pediatric patient * Information based on a clinical study of patients with SAD * New indication (not approved in pediatric patients) Antidepressant
11/28/2005 Amaryl glimepiride Type-2 Diabetes Mellitus * Data are insufficient to recommend pediatric use of glimepiride * In an active-controlled, single-blind, 24-week trial, 272 pediatric patients aged 8 to 17 years with Type 2 diabetes were randomized to treatment with glimepiride or metformin. Trial suggested differences favoring metformin * AE profile in the pediatric population was similar to that for adults * Information on PK parameters Antidiabetic
11/09/2005 Fluocinolone Acetonide Oil fluocinolone Chronic eczematous external otitis (outer ear) in children 2 years of age and older * Effectiveness established in studies of patients 2 years of age and older * New indication Anti-inflammatory, topical
10/28/2005 Trileptal oxcarbazepine Use as adjunctive therapy in children aged 2 years and above with epilepsy * Extended adjunctive therapy age range from 4 years down to 2 years * No evidence drug was effective as adjunctive therapy in patients < 2 years * In clinical studies as adjunctive therapy, apparent clearance (L/hr/kg) decreased when age increased such that children 2 to <4 years of age may require up to twice the dose per body weight compared to adults; and children 4 to d12 years of age may require a 50% higher dose per body weight compared to adults * Approximately 11% of pediatric patients < 4 years discontinued treatment because of adverse events including convulsions, status epilepticus and ataxia * Information on dose, PK parameters, AE profile and clinical studies Neurology        
10/19/2005 Levemir insulin detemir [rDNA origin] injection Type 1 diabetes Summary is pending Antidiabetic
10/06/2005 Norvir ritonavir Treatment of HIV-infection in combination with other antiretroviral agents * Extended age range from 2 years down to 1 month * AE profile in the pediatric population was similar to that for adults * Information on dose and PK parameters Antiviral
09/28/2005 Emtriva emtricitabine HIV-1 infection in combination with other antiretroviral agents * Safety and effectiveness in pediatric patients 3 months and older supported by data from 3 open-label, nonrandomized clinical studies * Safety and effectiveness in patients < 3 months have not been established * Relative bioavailability of Emtriva oral solution is approximately 80% of Emtriva capsules. Thus, maximum dosage is different for these 2 formulations: Solution max - 240 mg once daily; Capsules max - children weighing > 33 kg one 200 mg capsule once daily * The AE profile in pediatric patients was comparable to that observed in adults * Information on dose, PK parameters, AE profile and clinical studies * Antiviral
09/13/2005 NovoLog insulin aspart recombinant injection Diabetes Mellitus * In clinical studies comparing NovoLog to regular human insulin in patients 2 to 18 years with type 1 diabetes, NovoLog achieved glycemic control comparable to regular human insulin * The incidence of hypoglycemia was similar for both treatment groups Antidiabetic
08/11/2005 Mobic meloxicam Relief of signs and symptoms of pauciarticular or polyarticular course Juvenile Rheumatoid Arthritis * Safety and efficacy established in patients 2 years of age and older * Clinical studies evaluated doses ranging from 0.125 mg/kg/day to 0.375 mg/kg/day. There was no additional benefit demonstrated by doses above 0.125 mg/kg/day in the clinical trials. The lowest effective dose should be used * Adverse events in children were similar to those in adults including skin reactions and gastrointestinal bleed risk * Information on dose, PK parameters, AE profile and clinical studies Anti-inflammatory
08/04/2005 Loperamide Hydrochloride Soft Gelatin Capsules loperamide Control symptoms of diarrhea in children 12 years of age and older * New dosage form; new dosing regimen * No new clinical studies * Bioequivalence study in adults compared the current OTC drug (Imodium caplet) and this drug * Studies waived in children 0-2 years of age Antidiarrheal
07/29/2005 Avandia rosiglitazone Type 2 Diabetes Mellitus * Data are insufficient to recommend pediatric use of rosiglitazone * In a 24 week double-blind controlled trial in children with type 2 diabetes mellitus, aged 10 to 17 years, with a baseline BMI of 33 kg/m2 were randomized to treatment with rosiglitazone or metformin * Mean change from baseline in HbA1c was -0.14% with rosiglitazone and -0.49% with metformin * There was an insufficient number of patients to establish statistically whether these observed mean treatment effects were similar or different * Weight gain similar to that in adults * Information on PK parameters, and AE profile Antidiabetic
07/27/2005 Singulair Oral Granules, Tablets, and Chewable Tablets montelukast Relief of symptoms of perennial allergic rhinitis in children 6 months of age and older *Effectiveness was extrapolated from a allergic rhinitis study in patients 15 years of age and older * Safety in patients 6 to 23 months is supported by data from PK and safety and efficacy studies in asthma in this pediatric population and from adult PK studies * Studies waived in children < 6 months of age * New indication Antiasthmatic; antiallergy
07/21/2005 Adderall XR amphetamines mixed salts ADHD * Expanded labeling for 13-17 year olds * On a mg/kg body weight basis children 6-12 years have a higher clearance than adolescents or adults. Body weight is the primary determinant * There was not adequate evidence that doses greater than 20 mg/day conferred additional benefit in a placebo-controlled study conducted in adolescents aged 13-17 with ADHD * In a single-dose PK study in adolescents, isolated increases in systolic blood pressure (SBP) were observed in patients receiving 10 mg and 20 mg Adderall XR. Higher single doses were associated with a greater increase in SBP * Sustained increases in blood pressure should be treated with dose reduction and/or appropriate medication * Information on dose, PK parameters, and AE profile CNS Stimulant
06/29/2005 Topamax Tablets and Sprinkle Capsules topiramate Initial monotherapy for partial onset or primary generalized tonic-clonic seizures in children 10 years of age and older * Effectiveness established in studies of patients down to 6 years of age * Use in patients who were converted to monotherapy from a previous regimen of other anticonvulsant drugs have not been established in controlled trials * Provides information regarding treatment-emergent decrease in serum bicarbonate and adverse events * Some patients in the study discontinued therapy due to adverse events; however, adverse events associated with discontinuing therapy included difficulty with concentration/attention * Studies waived in children 0-2 years of age; deferred in children 2-10 years of age * New indication Anticonvulsant
06/21/2005 Keppra levetiracetam Adjunctive therapy in the treatment of partial onset seizures in patients with epilepsy * Extended indication from adults to patients 4 years and older * Safety and effectiveness have not been established in patients less than 4 years of age * PK analysis showed that clearance increased with an increase in body weight * Approximately 22% increase of apparent total body clearance of levetiracetam when co-administered with enzyme-inducing Anti-Epileptic Drugs (AEDs). Dose adjustment not necessary * 37.6% of pediatric patients reported behavioral symptoms compared to 13.3% in adults * Somnolence occurred in 22.8% in pediatric patients compared to 14.8% in adults * Information on dose, PK parameters, AE profile and clinical studies Anticonvulsant
05/26/2005 Focalin XR Extended-Release Capsules dexmethylphenidate Treatment of Attention-Deficit Hyperactivity Disorder in children 6 years of age and older * Should not be used in children under 6 years of age * Effectiveness in patients age 6 years of age and older was established in clinical studies * PK studies also conducted * Long-term effects in children have not been established * New dosage form CNS Stimulant
05/25/2005 Merrem I.V. meropenem Treatment of complicated skin and skin structure infections in children 3 months of age and older * Supported by extrapolating safety and effectiveness from an adequate and well-controlled adult study and additional data from pediatric PK studies * Studies waived for children < 3 months of age * New indication Antibiotic
05/18/2005 Invanz ertapenem Complicated Intra-abdominal Infections; Complicated Skin and Skin Structure Infections; Community Acquired Pneumonia; Complicated Urinary Tract Infections; Acute Pelvic Infections * Approved for use down to 3 months of age. Efficacy extrapolated from studies in adults and supported by PK and safety studies in pediatric patients * Not recommended in infants under 3 months of age as no data are available * Not recommended in the treatment of meningitis in the pediatric population due to lack of sufficient CSF penetration * Information on dose, PK parameters, AE profile and clinical studies Antibiotic
05/13/2005 Ortho Tri-Cyclen norgestimate/ ethinyl estradiol Evaluation of total hip bone mineral density in adolescent females with anorexia nervosa * No significant difference between Ortho Tri-Cyclen and placebo in mean change in total lumbar spine (L1-L4) and total hip bone mineral density in 123 adolescent females with anorexia nervosa in a double-blind, placebo-controlled, multicenter, one-year clinical trial Contraceptive
05/12/2005 Zyvox linezolid Central nervous system infections * PK data in pediatric patients with ventriculoperitoneal shunts showed variable cerebrospinal fluid (CSF) concentrations; therapeutic concentrations were not consistently achieved or maintained in the CSF * Use of linezolid for the empiric treatment of pediatric patients with central nervous system infections is not recommended * Additional information on efficacy in pediatric patients with infectious vancomycin-resistant Enterococcus faecium Antibiotic
05/06/2005 Doryx Delayed-Release Tablets doxycycline Treatment of infections * No new clinical studies submitted * PK data * Dosing information for new dosage form (to decrease esophagitis seen from capsules) * New dosage form Antibiotic
04/26/2005 Gemzar gemcitabine Refractory leukemia * Effectiveness in pediatric patients has not been demonstrated * Phase 1 trial in pediatric patients with refractory leukemia demonstrated a maximum tolerated dose; however, no meaningful clinical activity observed in a Phase 2 trial of gemcitabine in 22 patients with relapsed acute lymphoblastic leukemia and 10 patients with acute myelogenous leukemia * Toxicities observed were similar to those reported in adults Antineoplastic
03/30/2005 Asmanex Twisthaler mometasone furoate Maintenance treatment of asthma as prophylactic therapy • Approved for use in 12 years and older Antiasthmatic
03/25/2005 Zofran ondansetron Prevention of chemotherapy-induced and postoperative induced nausea and vomiting * Established dosing for surgical patients down to 1 month from 2 years of age * Established dosing for cancer patients down to 6 months from 4 years of age * Surgical and cancer patients < 18 years tend to have a higher ondansetron clearance compared to adults leading to a shorter half-life in most pediatric patients * The clearance of ondansetron in patients 1- 4 months of age is slower and the half-life is approximately 2.5 fold longer than patients who are > 4  24 months of age * Patients < 4 months of age receiving this drug should be closely monitored * Additional information on dose, PK parameters, AE profile and safety Antiemetic
03/11/2005 Rapamune sirolimus Prophylaxis of organ rejection in patients undergoing renal transplants * Safety and efficacy established in children 13 years or older judged to be at low to moderate immunologic risk * Safety was assessed in a controlled clinical trial in pediatric (<18 years of age) renal transplant recipients considered high immunologic risk. The use of Rapamune in combination with calcineurin inhibitors and corticosteroids was associated with an increased risk of deterioration of renal function, lipid abnormalities, and urinary tract infections * Safety and efficacy have not been established in pediatric patients less than 13 years old or in pediatric renal transplant recipients considered at high immunologic risk * Information on PK parameters, adverse events and safety Immunosuppressant
03/11/2005 Xopenex HFA Inhalation Aerosol levalbuterol Treatment of bronchospasm in patients with reversible obstructive airway disease in children 4 years of age and older * Extended indication for use in children down from 6 years of age * Pediatric patients have a lower exposure to the drug than adults * Population PK model developed from patients down to 4 years of age * Effectiveness and safety established from studies in adults, adolescents (12 years of age and older) and children ages 4-11 years of age with asthma. * Deferred studies in patients < 4 years of age * New active ingredient Antiasthmatic
03/03/2005 Clarinex D 24 Hour Extended Release Tablets desloratadine/pseudoephedrine Relief of nasal and non-nasal symptoms of seasonal allergic rhinitis, including nasal congestion, in patients 12 years of age and older * Two safety and effectiveness studies conducted in patients 12 years of age and older * PK study * Studies waived in children < 12 years of age * New active ingredient; new dosing regimen Antihistamine
02/18/2005 Celexa citalopram Major Depressive Disorder * Safety and effectiveness in the pediatric population have not been established * FDA required boxed warning for all antidepressants: Suicidality in Children and Adolescents - Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in short-term studies in children and adolescents with Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of Celexa or any other antidepressant in a child or adolescent must balance this risk with the clinical need. Patients who are started on therapy should be observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Celexa is not approved for use in pediatric patients. (See Warnings and Precautions: Pediatric Use) Pooled analyses of short-term (4 to 16 weeks) placebo-controlled trials of 9 antidepressant drugs (SSRIs and others) in children and adolescents with major depressive disorder (MDD), obsessive compulsive disorder (OCD), or other psychiatric disorders (a total of 24 trials involving over 4400 patients) have revealed a greater risk of adverse events representing suicidal thinking or behavior (suicidality) during the first few months of treatment in those receiving antidepressants. The average risk of such events in patients receiving antidepressants was 4%, twice the placebo risk of 2%. No suicides occurred in these trials * Two placebo-controlled trials in 407 pediatric patients with MDD have been conducted with Celexa, and the data were not sufficient to support a claim for use in pediatric patients Antidepressant
02/18/2005 Zoloft sertraline Major Depressive Disorder and Obsessive Compulsive Disorder * Safety and effectiveness in the pediatric population other than pediatric patients with OCD have not been established * FDA required boxed warning for all antidepressants: Suicidality in Children and Adolescents * Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in short-term studies in children and adolescents with Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of Zoloft or any other antidepressant in a child or adolescent must balance this risk with the clinical need. Zoloft is not approved for use in pediatric patients except for patients with obsessive compulsive disorder (OCD). (See Warnings and Precautions: Pediatric Use) Patients who are started on therapy should be observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Pooled analyses of short-term (4 to 16 weeks) placebo-controlled trials of 9 antidepressant drugs (SSRIs and others) in children and adolescents with major depressive disorder (MDD), obsessive compulsive disorder (OCD), or other psychiatric disorders (a total of 24 trials involving over 4400 patients) have revealed a greater risk of adverse events representing suicidal thinking or behavior (suicidality) during the first few months of treatment in those receiving antidepressants. The average risk of such events in patients receiving antidepressants was 4%, twice the placebo risk of 2%. No suicides occurred in these trials * Two placebo controlled trials in 373 pediatric patients with MDD have been conducted with Zoloft, and the data were not sufficient to support a claim for use in pediatric patients Antidepressant
01/12/2005 Paxil paroxetine Major Depressive Disorder * Safety and effectiveness in the pediatric population have not been established * FDA required boxed warning for all antidepressants: Suicidality in Children and Adolescents - Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in short-term studies in children and adolescents with Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of Paxil or any other antidepressant in a child or adolescent must balance this risk with the clinical need. Patients who are started on therapy should be observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Paxil is not approved for use in pediatric patients. (See Warnings and Precautions: Pediatric Use) Pooled analyses of short-term (4 to 16 weeks) placebo-controlled trials of 9 antidepressant drugs (SSRIs and others) in children and adolescents with major depressive disorder (MDD), obsessive compulsive disorder (OCD), or other psychiatric disorders (a total of 24 trials involving over 4400 patients) have revealed a greater risk of adverse events representing suicidal thinking or behavior (suicidality) during the first few months of treatment in those receiving antidepressants. The average risk of such events in patients receiving antidepressants was 4%, twice the placebo risk of 2%. No suicides occurred in these trials * Three placebo-controlled trials in 752 pediatric patients with MDD have been conducted with Paxil, and the data were not sufficient to support a claim for use in pediatric patients Antidepressant
01/12/2005 Remeron mirtazapine Major Depressive Disorder * Safety and effectiveness in the pediatric population have not been established * FDA required boxed warning for all antidepressants: Suicidality in Children and Adolescents - Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in short-term studies in children and adolescents with Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of Remeron or any other antidepressant in a child or adolescent must balance this risk with the clinical need. Patients who are started on therapy should be observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Remeron is not approved for use in pediatric patients. (See Warnings and Precautions: Pediatric Use) Pooled analyses of short-term (4 to 16 weeks) placebo-controlled trials of 9 antidepressant drugs (SSRIs and others) in children and adolescents with major depressive disorder (MDD), obsessive compulsive disorder (OCD), or other psychiatric disorders (a total of 24 trials involving over 4400 patients) have revealed a greater risk of adverse events representing suicidal thinking or behavior (suicidality) during the first few months of treatment in those receiving antidepressants. The average risk of such events in patients receiving antidepressants was 4%, twice the placebo risk of 2%. No suicides occurred in these trials * Two placebo-controlled trials in 258 pediatric patients with MDD have been conducted with Remeron and the data were not sufficient to support a claim for use in pediatric patients Antidepressant
01/12/2005 Serzone nefazodone Major Depressive Disorder * Safety and effectiveness in the pediatric population have not been established * FDA required boxed warning for all antidepressants: Suicidality in Children and Adolescents - Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in short-term studies in children and adolescents with Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of Serzone or any other antidepressant in a child or adolescent must balance this risk with the clinical need. Patients who are started on therapy should be observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Serzone is not approved for use in pediatric patients. (See Warnings and Precautions: Pediatric Use) Pooled analyses of short-term (4 to 16 weeks) placebo-controlled trials of 9 antidepressant drugs (SSRIs and others) in children and adolescents with major depressive disorder (MDD), obsessive compulsive disorder (OCD), or other psychiatric disorders (a total of 24 trials involving over 4400 patients) have revealed a greater risk of adverse events representing suicidal thinking or behavior (suicidality) during the first few months of treatment in those receiving antidepressants. The average risk of such events in patients receiving antidepressants was 4%, twice the placebo risk of 2%. No suicides occurred in these trials * Two placebo-controlled trials in 286 pediatric patients with MDD have been conducted with Serzone, and the data were not sufficient to support a claim for use in pediatric patients Antidepressant
12/28/2004 Clolar clofarabine Relapsed or refractory acute lymphoblastic leukemia after at least two prior regimens * Labeling for patients 1 to 21 years old. This use is based on the induction of complete responses * Randomized trials demonstrating increased survival or other clinical benefit have not been conducted * Information on dose, PK parameters, and AE profihe Antineoplastic
12/22/2004 Pataday Ophthalmic Solution olopatadine Treatment of ocular itching associated with allergic conjunctivitis (itchy eyes) in children 3 years of age and older * Based on clinical trials that included patients down to 3 years of age. * New indication Antihistamine, topical
12/17/2004 Augmentin ES-600 Powder for Oral Suspension amoxicillin; clavulanate Treatment of acute bacterial sinusitis (ABS) (sinus infection) in children 3 months of age and older * No new pediatric studies * Effectiveness extrapolated from adult studies for Augmentin XR for ABS and from studies in pediatric patients with otitis media and by similar pharmacokinetics in pediatric patients * New indication Antibiotic
12/16/2004 VisionBlue Ophthalmic Solution trypan blue Aid in ophthalmic surgery by staining anterior capsule * Approved for use in all populations based on information from clinical trials in the literature * New drug Ophthalmologic stain
12/10/2004 Agrylin anagrelide Myeloproliferative disorders * An open-label study evaluated PK/PD but not efficacy. * Information on PK/PD profile, dosing, AEs, and safety in patients > 6 years to 17 years * No overall difference in dosing and safety were observed between pediatric and adult patients * Established recommended starting dose based on limited data. Dosage should be adjusted to the lowest effective dosage Hematology/Coagulation
11/16/2004 Zomig zolmitriptan Migraine * Clinical trial evaluating zolmitriptan in pediatric patients ages 12 -17 years did not establish the safety and effectiveness when compared to placebo * AEs observed in clinical trials were similar to those observed in clinical trials in adults. Antimigraine
10/21/2004 Concerta methylphenidate ADHD * Expanded labeling for 13-17 year olds including information on dose, PK parameters, and AE profile * Increase in age resulted in increased apparent oral clearance * For patients new to methylphenidate: higher maximum recommended dosage for adolescents compared to children 6-12 years of age * Data are inadequate to determine whether chronic use of stimulants in children may cause suppression of growth. Therefore, growth should be monitored during treatment * Safety and efficacy in children <6 years have not been established CNS Stimulant
10/13/2004 Imitrex Nasal Spray sumatriptan Migraine * Five clinical trials evaluating oral sumatriptan in pediatric patients ages 12 -17 years did not establish the safety and effectiveness when compared to placebo * Postmarketing experience documents that serious AEs rarely reported in adults, including stroke, visual loss, and death have occurred in the pediatric population after use of subcutaneous, oral, and/ or nasal sumatriptan. * Since clinical data to determine the frequency of serious adverse events in pediatric patients who might receive injectable, oral, and/ or intranasal sumatriptan are not presently available, the use of sumatriptan in patients aged younger than 18 years is not recommended Antimigraine
09/29/2004 Amlexanox Mucoadhesive Patch amlexanox Treatment of apthous ulcers in children 12 years of age and older * Approval based on monograph and previous studies for other indication * No new studies submitted * Studies in children birth  12 years of age waived * New indication Anti-inflammatory, topical
09/01/2004 Clarinex desloratadine Seasonal and perennial allergic rhinitis, and the symptomatic relief of pruritus, and hives * Indicated for seasonal allergic rhinitis down to 2 years of age. Extended age range down to 6 months for perennial allergic rhinitis and chronic idiopathic urticaria * Safety and effectiveness of tablets or syrup has not been established in pediatric patients less than 6 months of age * Information on dose, PK parameters, and AE profile in pediatric patients 6 months - 11 years of age Antihistamine
08/19/2004 Vioxx rofecoxib Pauciarticular or polyarticular course Juvenile Rheumatoid Arthritis * Merck announced a voluntary worldwide withdrawal of Vioxx (rofecoxib) due to safety concerns on September 30, 2004. Anti-inflammatory
08/13/2004 Ferrlecit sodium ferric gluconate complex Iron deficiency anemia in chronic hemodialysis patients receiving supplemental erythropoietin therapy * Safety and effectiveness established in pediatric patients 6 -15 years old * Patients <6 years of age not studied * Information on dose, PK parameters and AE profile Vitamin
07/30/2004 Claritin-D 12 Hour Extended-Release Tablets Claritin-D 24 Hour Extended-Release Tablets loratadine; pseudoephedrine Temporary relief of nasal congestion due to the common cold in children 12 years of age and older OTC * Approval based on monograph and previous studies for other indication * No new studies submitted * Studies in children birth - 12 years of age waived * New indication Antihistamine
06/24/2004 Camptosar irinotecan Refractory solid tumors * Effectiveness in pediatric patients has not been established * Adverse event profile from a Phase 2 trial with 170 children with refractory solid tumors comparable to that seen in adults; Grade 3-4 neutropenia experienced by 54 (31.8%) patients, neutropenia complicated by fever in 15 (8.8%) patients, Grade 3-4 diarrhea observed in 35 (20.6%) patients. * Accrual for phase 2 study with 21 children with previously untreated rhabdomyosarcoma halted due to high rate (23.6%) of progressive disease and early deaths (14%) * Adverse event profile seen in the 21 children different than that observed in adults; most significant Grade 3 or 4 adverse events were dehydration experienced by 6 patients (28.6%) associated with severe hypokalemia in 5 patients (23.8%) and hyponatremia in 3 patients (14.3%); in addition Grade 3-4 infection was reported in 5 patients (23.8%)(across all courses of therapy and irrespective of causal relationship) * PK parameters comparable to adults * Minimal accumulation of irinotecan and SN-38 (active metabolite) observed in children on daily dosing Antineoplastic
06/24/2004 TamiFlu oseltamivir Treatment of uncomplicated acute illness due to influenza infection in patients 1 year and older * Not recommended in pediatric patients less than 1 year of age because of uncertainties regarding the rate of development of the human blood-brain barrier and the unknown clinical significance of animal toxicology data for human infants Antiviral
06/21/2004 Codeprex Extended-Release Suspension chlorpheniramine; codeine Temporary relief of cough associated with the common cold or inhaled irritants; temporary relief of symptoms of hay fever, other upper respiratory allergies, or allergic rhinitis in children 6 years of age and older OTC * Approval and age range based on monograph for antitussives and antihistamine * No clinical studies submitted * Studies in children < 6 years of age deferred * New dosage form; new dosing regimen Antihistamine
06/17/2004 Prevacid lansoprazole Short-term treatment of symptomatic GERD and erosive Esophagitis * Expanded age range to include patients 12 -17 years of age; previously labeled only in pediatric patients 1-11 years of age * Safety and effectiveness in pediatric patients <1 year of age have not been established * Information on dose, PK parameters, and AE profile Antiulcerative
06/02/2004 Humalog Injection insulin lispro Treatment of patients with diabetes mellitus for the control of hyperglycemia (high blood sugar) in children 3-11 years of age * Safety and effectiveness established from studies in patients 3-11 years of age * Dosing information added for external insulin pumps * New route of administration Antidiabetic
05/25/2004 Axid nizatidine Esophagitis, and heartburn due to GERD * Indicated in pediatric patients 12 years and older * Information on dose, PK parameters, and AE profile Antiulcerative
05/06/2004 Lidosite Topical System Kit epinephrine; lidocaine Topical local analgesia for superficial dermatological procedures in children 5 years of age and older * 505(b)(2) with clinical studies * Safety and effectiveness established in studies of pediatric patients 5-18 years of age * PK study in pediatric patients 6-15 years of age dosing regimen established in clinical trials * Studies in patients 0-5 years of age deferred * New dosage form; new route of administration Anesthetic, topical
05/05/2004 Effexor and Effexor XR venlafaxine Major Depressive Disorder * Effectiveness in pediatric patients has not been established * FDA required boxed warning for all antidepressants: Suicidality in Children and Adolescents - Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in short-term studies in children and adolescents with Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of Effexor or any other antidepressant in a child or adolescent must balance this risk with the clinical need. Patients who are started on therapy should be observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Effexor is not approved for use in pediatric patients. (See Warnings and Precautions: Pediatric Use) Pooled analyses of short-term (4 to 16 weeks) placebo-controlled trials of 9 antidepressant drugs (SSRIs and others) in children and adolescents with major depressive disorder (MDD), obsessive compulsive disorder (OCD), or other psychiatric disorders (a total of 24 trials involving over 4400 patients) have revealed a greater risk of adverse events representing suicidal thinking or behavior (suicidality) during the first few months of treatment in those receiving antidepressants. The average risk of such events in patients receiving antidepressants was 4%, twice the placebo risk of 2%. No suicides occurred in these trials. * 18% of Effexor XR treated patients (6-17 years) versus 3.6 % of placebo treated patients experienced a weight loss of at least 3.5 % in both MDD and the GAD studies * In an open-label study increases in weight were less than expected based on data from age and sex matched peers. The difference between observed weight gain was larger for children less than 12 years than for adolescents older than 12 years * During an 8 week placebo controlled GAD trial, Effexor XR treated patients ages 6-17 years grew an average of 0.3 cm, while placebo treated patients grew an average of 1 cm. In a 6 month open-label study, height increases that were less than expected based on data from age and sex matched pairs. The difference between observed and expected growth rates were larger for children less than 12 years than for adolescents older than 12 years * Decreased appetite observed in 10% of patients ages 6-17 years old receiving Effexor XR * Occurrence of blood pressure and cholesterol increases considered clinically relevant in pediatric patients similar to that observed in adults Antidepressant
04/29/2004 Mucinex DM Extended-release Tablet guaifenesin; dextromethorphan Expectorant and cough suppressant in children 12 years of age and older * 505(b)(2) approved with no pediatric information * Age range based on monograph * Do not use in children under 12 years of age * studies waived in children < 12 years of age due to safety concerns * New dosage form Cough suppressant
04/21/2004 Advair Diskus fluticasone/ salmeterol Asthma * Extended indication from 12 years down to 4 years of age Antiasthmatic
04/14/2004 Detrol LA tolterodine Urinary frequency and urge incontinence due to neurogenic conditions * Efficacy in pediatric population has not been demonstrated * The dose-plasma concentration relationship is linear in patients from 11 to 15 years * Parent/ metabolite ratios differed according to CYP2D6 metabolizer status * 710 pediatric patients ages 5 -10 years with urinary frequency and urge incontinence were studied in 2 randomized placebo controlled trials. Urinary tract infections were higher in patients treated with Detrol LA (6.6%) compared to placebo (4.5%) * Aggressive, abnormal and hyperactive behavior and attention disorders occurred in 2.9% of children treated with Detrol LA compared to 0.9% treated with placebo Urology
04/14/2004 Trusopt dorzolamide Reduction in intraocular pressure * Safety and IOP-lowering effects have been demonstrated in pediatric patients * Adverse event profile was comparable to that seen in adults Ophthalmologic hypotensive
04/01/2004 Corlopam fenoldopam Indicated for the in-hospital, short-term reduction in blood pressure * Indicated for the in-hospital, short-term (up to 4 hours) reduction in blood pressure in pediatric patients <1 month (at least 2 kg) to 12 years of age * Information on PK, dose and AE profile * Clinical studies did not include patients 12  16 years of age Antihypertensive
03/31/2004 Zemplar paricalcitol Secondary hyperparathyroidism associated with end stage renal disease * Safety and effectiveness were examined in a 12 week randomized, double-blind, placebo-controlled study of 29 pediatric patients aged 5-19 years old with end stage renal disease on hemodialysis; information * Primary efficacy analysis revealed 9 of 15 patients in Zemplar group had 2 consecutive 30 % decreases from baseline intact PTH compared with 3 of 14 patients in placebo group * No patients in either group developed hypercalcemia (defined as at least one calcium value >11.2 mg/dL) during study Vitamin D analog
03/25/2004 Cipro ciprofloxacin Complicated UTI and pyelonephritis * Indicated for the treatment of complicated urinary tract infections (cUTIs) and pyelonephritis in pediatric patients 1  17 years of age * Not drug of first choice due to increased adverse events compared to controls including events related to joints and/or surrounding tissues * Information on PK and dose in pediatric patients 1  17 years of age * The most frequent adverse events observed within 6 weeks of treatment initiation during the cUTI clinical trial were gastrointestinal 15% compared to 9% and musculoskeletal 9.3% compared to 6% in ciprofloxacin-treated compared to control-treated patients, respectively Antibiotic
03/19/2004 Viracept nelfinavir HIV-1 * Safety and effectiveness established in patients 2  13 years of age * New twice daily dosing regimen and modified three times daily dosing for pediatric patients > 2 years * A reliably effective dose not established in patients <2 years of age * PK information in pediatric patients from birth to 13 years of age * Highly variable drug exposure is a significant problem in pediatric patients * Adverse event profile was similar to that for adults Antiviral
03/15/2004 Glucovance glyburide/ metformin Type 2 Diabetes Mellitus * As studied in active-controlled, double blind trial in pediatric patients (9  16 years of age), Glucovance was not statistically superior to either metformin or glyburide in reducing HbA1C from baseline * No unexpected safety findings Antidiabetic
03/11/2004 Cozaar losartan Hypertension * Antihypertensive effects established in hypertensive patients 6-16 years of age * Not recommended for pediatric patients less than 6 years or with glomerular filtration rate < 30mL/ min/1.73 m2 due to no data * Information on PK and dose in pediatric patients 6-16 years of age. * No relevant differences between the AE profile for pediatric patients compared to reported AEs for adults * Information on preparation of a suspension Antihypertensive
03/08/2004 Ultiva remifentanil Maintenance of anesthesia * Safety and efficacy for the maintenance of anesthesia established from birth to 1 year of age * Recommended dosing guidelines for maintenance of anesthesia for patients from birth to 2 months * The clearance rate observed in neonates was highly variable  approximately 2 times higher than young healthy adults * Individual doses for each patient should be carefully titrated Anesthetic agent
03/05/2004 Arava leflunomide Polyarticular Juvenile Rheumatoid Arthritis * Safety and efficacy in pediatric patients with polyarticular JRA have not been fully evaluated * 94 patients with polyarticular JRA were studied in a double-blind active controlled trial (1:1 randomization); approximately 68% of pediatric patients receiving Arava versus 89% receiving active comparator demonstrated improvement on the primary endpoint by week 16 * Pediatric patients with a body weight d 40 kg have a reduced clearance relative to adult rheumatoid arthritis patients * Information on PK of M1, the active metabolite responsible for in vivo activity in children 3-17 years old * Most common adverse events in 74 polyarticular JRA patients 3-17 years old included abdominal pain, diarrhea, nausea, vomiting, oral ulcers, upper respiratory tract infections, alopecia, rash, headache, and dizziness * 14 of the 74 patients experienced ALT and/or AST elevations; 5/14 were between 3 and 8 fold the upper limit of normal Anti-inflammatory
03/02/2004 Lotensin benazepril Hypertension * Information on dose, PK in pediatric patients 6-16 years of age * Not recommended for pediatric patients less than 6 years or with glomerular filtration rate < 30mL/min/1.73 m2 due to insufficient data * Infants below the age of 1 year should not be given ACE inhibitors due to concerns over possible effects on kidney development * The clearance rate was substantially higher in hypertensive children and adolescents than that of healthy adults * The terminal half life (t1/2) in pediatric patients was one third of that observed in adults * Adverse event profile in pediatric patients was similar to that seen in adults * Information on preparation of a suspension Antihypertensive
02/27/2004 Myfortic Delayed-Release Tablets mycophenolic acid Prevention of organ rejection in patients receiving allogeneic renal transplants in children 5-16 years of age with stable renal transplants * Approval based on extrapolation of safety and effectiveness in adult patients * One PK study with information down to 5 years of age * Waived studies in birth to 10 years because there are too few children to study. * New active ingredient Immunosuppressant
02/24/2004 Children's Advil Allergy Sinus Suspension chlorpheniramine; ibuprofen; pseudoephedrine Symptoms of allergic rhinitis (runny nose) and the common cold in children 6 years of age and older * Effectiveness extrapolated from adult studies * Bioequivalence studies in healthy adults * PK and safety studies in children 6 to 12 years of age * New dosage form Antihistamine
01/15/2004 Zithromax Tablets azithromycin Treatment of acute bacterial sinusitis (sinus infection) in patients 6 months of age and older * Effectiveness extrapolated from adult sinusitis studies and from pediatric acute otitis media studies * Clinical studies conducted in pediatric patients 3 years to 16 years of age to determine PK and safety for oral suspension * Safety and effectiveness in patients under 6 months of age have not been established * Side effects seen in pediatric patients were comparable to those seen in adults, with different incidence rates for the dosage regimens recommended in pediatric patients * Dosing regimen established * Partial waiver < 6 months of age because too few patients to study * New indication Antibiotic
01/08/2004 Norvasc amlodipine Hypertension * Information on dose, PK in pediatric patients 6-17 years of age * Adverse event profile in pediatric patients was similar to that seen in adults Antihypertensive
12/12/2003 Xenical orlistat Obesity management * Use in 12-16 year olds is supported by studies in adults with additional data from a 54 week safety and efficacy study in obese adolescent patients. * Since orlistat can reduce absorption of fat soluble vitamins, all patients should take a daily multivitamin supplement containing fat soluble vitamins. * Adverse event profile in adolescent patients was similar to that seen in adults Obesity management
12/10/2003 Ertaczo Cream sertaconazole Treatment of interdigital tinea pedis (athlete's foot) in children 12 years of age and older * Safety and effectiveness established in clinical trials involving adolescent patients * Studies in patients less than 12 years of age waived because there are too few children with the disease to study * New drug Antifungal, topical
12/02/2003 Malarone atovaquone/ proguanil Prophylaxis and treatment of malaria * Safety and effectiveness established down to e 11kg * Information on dose, efficacy, PK parameters and AE profile * Elimination half-life is shorter in pediatric patients (1 to 2 days) than in adults (2 to 3 days) * Attributable AEs occurring in ³ 5% of the pediatric patients were vomiting (10%) and pruritus (6%) Antimalarial
10/16/2003 Elestat Ophthalmic Solution epinastine Prevention of itching associated with allergic conjunctivitis in children 3 years of age and older * Based on effectiveness and safety studies that included children down to 10 years of age * Partial waiver for children < 3 years of age because the condition does not exist in the age group * New drug Antihistamine, topical
10/10/2003 Denavir Cream penciclovir Treatment of recurrent herpes labialis (cold sores) in children 12 years of age and older * Extended indication down from 18 years of age to 12 years of age * Effectiveness extrapolated from adult studies * Safety study in patients 12-17 years of age * Pediatric submission Antiviral, topical
09/30/2003 Floxin Otic Solution ofloxacin Treatment of otitis externa (outer ear infection) in children 6 months of age and older * Dosing change from 2 times daily to 1 time daily for 7 days based on effectiveness and safety studies that included pediatric patients * New dosing regimen Antibiotic
08/01/2003 Fludara fludarabine Refractory acute leukemia and solid tumors * Fludarabine was evaluated in 62 pediatric patients and the data were insufficient to establish efficacy in any childhood malignancy Antineoplastic
07/18/2003 Ciprodex Sterile Otic Suspension ciprofloxacin; dexamethasone Treatment of acute otitis media in patients with tympanostomy tubes (inner ear infection) in children 6 months of age and older treatment of acute otitis externa (outer ear infection) in children 6 months of age and older * Over 700 pediatric patients in safety and effectiveness studies to support both indications * Pediatric dosing information added * New dosage form Antibiotic, topical
07/01/2003 Zestril lisinopril Hypertension * Labeling for 6-16 years of age * Not recommended for pediatric patients less than 6 years or with glomerular filtration rate < 30mL/min/1.73m2 * Information on dose, efficacy and pharmacokinetics * No relevant differences were identified between adverse experience profile for pediatric patients and that previously reported for adult patients * Information on preparation of a suspension Antihypertensive
05/29/2003 Prinivil lisinopril Hypertension * Labeling for 6-16 years of age * Not recommended for pediatric patients with glomerular filtration rate < 30ml/min/1.73m2 * Information on dose, efficacy and pharmacokinetics * No relevant differences were identified between adverse experience profile for pediatric patients and that previously reported for adult patients * Information on preparation of a suspension Antihypertensive
05/27/2003 Monopril fosinopril Hypertension * New data from a double-blind study in 252 patients 6-16 years of age * New recommended dose in children weighing more than 50kg * New Information on PK parameters * An appropriate dosage strength is not available for children weighing less than 50kg Antihypertensive
05/23/2003 Duocaine Injection bupivacaine; lidocaine Local regional anesthesia for ophthalmologic surgery by peripheral nerve block techniques in children 12 years of age and older * Safety and effectiveness extrapolated from existing clinical database * Safety and effectiveness not established in patients < 12 years of age * Partial waiver 0-12 years of age because general anesthesia is preferred in that population * New active ingredient Anesthetic, topical
05/20/2003 Duragesic fentanyl Management of chronic pain * Safety evaluated in three open-label trials in 291 patients 2 years through 18 years of age with chronic pain * New Warning: Duragesic should be administered to children only if they are opioid-tolerant and age 2 years or older * New information on pharmacokinetics, dosage and administration and patient information * Precaution to guard against accidental ingestions by children * Adverse Events: no apparent pediatric-specific risk associated with Duragesic use in children as young as 2 years old when used as directed. Most common adverse events were fever (35%), vomiting (33%), and nausea (24%) Anesthetic agent
05/12/2003 Allegra fexofenadine Allergic rhinitis * Three clinical safety studies in 845 children with allergic rhinitis are described in the label Antihistamine
05/01/2003 Flonase Nasal Spray & Cultivate Ointment fluticasone Flonase - nasal symptoms of seasonal and perennial allergic and nonallergic rhinitis Cutivate Ointment - corticosteroid-responsive dermatoses Flonase * New data from 1-year placebo-controlled clinical growth study in pediatric patients 3-9 years of age; no statistically significant effect on growth was noted compared to placebo. No evidence of clinically relevant changes in HPA axis function or bone mineral density was observed as assessed by 12-hour urinary cortisol excretion and dual-energy x-ray absorptiometry, respectively. Cutivate * Indicated for use only in adult patients * In a study of 35 pediatric patients treated for atopic dermatitis, subnormal adrenal function was observed with cosyntropin stimulation testing Anti-inflammatory, topical
04/15/2003 Methylin Chewable Tablets methylphenidate Treatment of Attention-Deficit Hyperactivity Disorder in children 6 years of age and older treatment of narcolepsy in children 6 years of age and older * Bioequivalence studies in adults * New dosage form CNS Stimulant
04/15/2003 Ditropan & Ditropan XL oxybutynin Detrusor Overactivity Associated with a Neurological Condition Ditropan * Additional information on dose and PK parameters * Precautions section of label updated Ditropan XL * Safety and effectiveness established down to 6 years of age Urology
04/15/2003 Vigamox moxifloxacin Bacterial Conjunctivitis * Safety and effectiveness established down to 1 year of age Antibiotic, topical
03/11/2003 Temodar temozolomide Recurrent CNS tumors * Temozolomide effectiveness in children has not been demonstrated * New data from 2 open-label Phase 2 studies in pediatric patients 3-18 years of age. In one study there were 29 patients with recurrent brain stem glioma and 34 patients with recurrent high grade astrocyoma. In a second study there were 122 patients enrolled with various types of tumors; 113 CNS tumors and 9 non-CNS tumors. * The temozolomide toxicity profile in children is similar to adults Antineoplastic
02/26/2003 Pulmicort budesonide Maintenance and Prophylaxis of Asthma * Safety information in pediatric patients 6 to 12 months of age * A dose dependent effect on growth was observed in the 12-week trial which supports the finding that the use of Pulmicort Respules in infants 6 to 12 months of age may result in systemic effects and is consistent with the findings of growth suppression in other studies with inhaled corticosteroids * Pneumonia was observed more frequently in patients treated with Pulmicort Respules than in patients treated with placebo Antiasthmatic
01/17/2003 Lamictal lamotrigine Adjunctive therapy for partial seizures * Extended indication from adults to pediatric patients e 2 years * Patients aged 2 - 18 years had clearance influenced predominantly by total body weight and concurrent antiepileptic drug (AED) therapy. The oral clearance was higher, on a body weight basis, in pediatric patients than in adults * Because of increased clearance in pediatrics, maintenance doses in patients weighing < 30 kg may need an increase of as much as 50% based upon clinical response * Evidence shows that the inclusion of VPA in a multi-drug regimen increases the risk of serious, potentially life-threatening rash in pediatric patients * Approximately 11.5% of the 1,081 pediatric patients who received the drug as adjunctive therapy in clinical trials discontinued treatment because of an AE Anticonvulsant
01/13/2003 Busulfex busulfan Part of a conditioning regimen administered prior to hematopoietic progenitor cell transplantation for a variety of malignant hematologic or non-malignant diseases * The population pharmacokinetic estimates of busulfan for clearance and volume of distribution were determined in an open-label, uncontrolled PK study in 24 pediatric patients 5 months to 16 years who received busulfan as part of a conditioning regimen administered prior to hematopoietic progenitor cell transplantation for a variety of malignant hematologic or non-malignant diseases * Suggested dosing regimen Antineoplastic
01/03/2003 Prozac fluoxetine Major Depressive Disorder (MDD) & Obsessive Compulsive Disorder (OCD) * Effectiveness established in patients 7-17 years of age for OCD * Effectiveness established in patients 8-17 years of age for MDD * FDA required boxed warning for all antidepressants: Suicidality in Children and Adolescents - Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in short-term studies in children and adolescents with Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of Prozac or any other antidepressant in a child or adolescent must balance this risk with the clinical need. Patients who are started on therapy should be observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Prozac is approved for use in pediatric patients with MDD and obsessive compulsive disorder (OCD). (See Warnings and Precautions: Pediatric Use) Pooled analyses of short-term (4 to 16 weeks) placebo-controlled trials of 9 antidepressant drugs (SSRIs and others) in children and adolescents with major depressive disorder (MDD), obsessive compulsive disorder (OCD), or other psychiatric disorders (a total of 24 trials involving over 4400 patients) have revealed a greater risk of adverse events representing suicidal thinking or behavior (suicidality) during the first few months of treatment in those receiving antidepressants. The average risk of such events in patients receiving antidepressants was 4%, twice the placebo risk of 2%. No suicides occurred in these trials * Decreased weight gain has been observed in association with the use of fluoxetine, as with other SSRIs. In one 19-week clinical trial pediatric subjects treated with fluoxetine gained an average of 1.1cm less in height (p=0.004) and 1.1 kg less in weight (p=0.008) than those treated with placebo. Therefore, height and weight should be monitored periodically in pediatric patients treated with fluoxetine * Mania/hypomania led to discontinuation of 1.8% of fluoxetine treated patients vs. 0% of placebo controlled patients in the three placebo-controlled trials combined. Regular monitoring for the occurrence of mania/hypomania is recommended * Higher average steady state fluoxetine and norfluoxetine concentrations were observed in children than in adolescents. These differences were almost entirely explained by differences in weight * Separate dosing recommendations in lower weight children Antidepressant
12/31/2002 Singulair Oral Granules, Tablets, and Chewable Tablets montelukast Seasonal allergic rhinitis in children 2 years of age and older *Effectiveness extrapolated from studies in patients 15 years of age and older and supported with one pediatric safety trial in patients 2-14 years of age *New indication Antiasthmatic; antiallergy
12/30/2002 Zovirax Cream acyclovir Treatment of herpes labialis (cold sores) in children 12 years and older * Adolescents 12-17 years of age included in clinical safety studies. * dosing regimen established waived in children < 12 years of age because rarely seen in that population * New dosage form Antiviral
12/26/2002 Relpax eletriptan Migraine *Su mmary is pending Antimigraine
12/19/2002 Zyvox linezolid Nosocomial pneumonia, community-acquired pneumonia, complicated and uncomplicated skin and skin structure infections, and vancomycin-resistant infections caused by susceptible strains * Extended age range down to birth for nosocomial pneumonia, community-acquired pneumonia, complicated skin and skin structure infections and vancomycin-resistant infections. Safety and efficacy extrapolated from studies in adults and supported by PK and comparator-controlled studies in patients from birth to 11 years * Extended age range down to 5 years of age for uncomplicated skin and skin structure infections based upon a comparator-controlled study in 5 to 17 year olds * Clearance of linezolid varies as a function of age; As age of pediatric patients increases, clearance gradually decreases, and by adolescence mean clearance values approach those observed in adults * Pediatric patients exhibit wider variability in clearance and systemic exposure (AUC) compared with adults * New every 8 hours dosing regimen for pediatric patients birth to 11 years of age and every 12 hours dosing regimen for pediatric patients 12 years and older * Information on PK parameters, AE profile, laboratory changes, dosing, and clinical studies Antibiotic
12/04/2002 Centany Ointment 2% mupirocin Treatment of impetigo in children 2 months of age and older * New dosage form: ointment that differed from already approved ointment with pediatric clinical trials to demonstrate equivalence Antibiotic, topical
11/26/2002 Strattera atomoxetine Attention-Deficit Hyperactivity Disorder * Safety and effectiveness established down to 6 years of age * It is unknown whether final adult height or weight is affected by treatment. Patients on long-term treatment should be monitored * The effectiveness of atomoxetine beyond 9 weeks and safety beyond 1 year in pediatric patients, has not been systematically evaluated in controlled trials Non-stimulant ADHD treatment
11/05/2002 Navelbine vinorelbine Malignant tumors * New data from a single-arm study in 46 patients with recurrent solid malignant tumors, including rhabdomyosarcoma /undifferentiated sarcoma, neuroblastoma, and CNS tumors, at doses similar to those used in adults showed no meaningful clinical activity Antineoplastic
10/29/2002 Pravachol pravastatin Heterozygous Familial Hypercholesterolemia * New indication in boys and girls 8-18 years of age Antilipemic
10/21/2002 Zyrtec cetirizine Perennial Allergic Rhinitis & Chronic Urticaria * Extended the age range from 2 years to 6 months * Information on dose, PK parameters and AE profile Antihistamine
10/18/2002 Zocor simvastatin Heterozygous Familial Hypercholesterolemia * New indication in adolescent boys and girls (at least one year post-menarche) 10-17 years of age Antilipemic
10/18/2002 Lipitor atorvastatin Heterozygous Familial Hypercholesterolemia * New indication in adolescent boys and girls (post-menarche) 10-17 years of age Antilipemic
10/08/2002 Epivir lamivudine HIV * Lamivudine clearance substantially reduced in 1-week-old neonates relative to pediatric patients >3 months of age Antiviral
08/30/2002 Nolvadex tamoxifen McCune-Albright Syndrome * A study in 28 female patients aged 2-10 years with McCune-Albright Syndrome and precocious puberty did not demonstrate safety and effectiveness. Long term effects have not been established * Mean uterine volume increased after 6 months of therapy and doubled at end of 1-year study Hormone
08/26/2002 DUAC Topical Gel clindamycin 1%/benzoyl peroxide 5% Acne * Added combination topical treatment for mild to moderate acne Antiacne, topical
07/26/2002 Singulair montelukast Prophylaxis and chronic treatment of asthma *Safety and effectiveness established in patients 12 months to 5 years of age *Information on dose, PK parameters and AE profile in patients 12-23 months and 2-5 years *New 4mg chewable tablet and 4mg oral granule formulations developed. The chewable tablets contain aspartame whereas the oral granule formulation does not Antiasthmatic
07/17/2002 Nasonex-nasal Elocon - topical mometasone Nasonex - Perennial and seasonal allergic rhinitis Elocon - Relief of inflammatory and pruritic manifestations of corticosteroid dermatose * Nasonex Nasal Spray * Extended age range from 3 years down to 2 years * In a clinical study in which pediatric patients 2-5 years were treated with mometasone nasal spray for up to 42 consecutive days, no significant effect on adrenal function was found * Upper respiratory tract infection was more common with Nasonex (2/28) compared to placebo (0/28) * Elocon Cream & Ointment * Evidence of HPA axis suppression in pediatric patients 6-23 months of age * Outlined local AE's as well as skin atrophy in pediatric patients 6-23 months of age * Approved down to 2 years of age as in previous labeling * Elocon Lotion * Safety and effectiveness have not been established in pediatric patients below 12 years of age and use <12 year old is not recommended * Should not be used for the treatment of diaper dermatitis Anti-inflammatory, topical
07/12/2002 Prilosec omeprazole Gastroesophageal reflux and erosive esophagitis * Safety and effectiveness established in pediatric patients 2-16 years of age * Information on dose, PK parameters, exposure/response and AE profile Antiulcerative
06/26/2002 Clarinex RediTabs Orally Disintegrating Tablets desloratadine Allergic rhinitis and chronic ideopathic urticaria * Approved for use down to 12 years of age; new formulation Antihistamine
06/06/2002 Pepcid famotidine Gastroesophageal reflux * Labeling for patients less than 1 year of age including information on dose, PK/PD parameters and AE profile * Lower dose recommended in patients <3 months of age * Pediatric patients 0-3 months of age had clearance values 2 to 4-fold less than those in older patients and adults * In a clinical study of 35 pediatric patients <1 year of age, agitation was observed in 5 patients on famotidine and resolved upon discontinuation of the drug Antiulcerative
06/05/2002 Ritalin LA Capsules methylphenidate Attention Deficit Hyperactivity Disorder * Approved for use in 6-12 years of age; once a day dose in the morning CNS Stimulant
05/10/2002 QVAR beclomethasone dipropionate Maintenance treatment of asthma as prophylactic therapy Summary is pending Antiasthmatic
05/02/2002 Accutane isotretinoin Severe recalcitrant nodular acne * Safety and effectiveness information on pediatric patients 12-17 years of age * Identified an increased incidence of back pain, arthralgia and myalgia in pediatric patients * New General Precautions subsection- caution when prescribing Accutane to pediatric patients with disorders of bone metabolism, such as osteoporosis and osteomalacia * Adolescents who participate in sports with a repetitive impact may be at increased risk for bone related injuries * In an open-label study of pediatric patients (n=217) given a single course of therapy, 16 (7.9%) had decreases in lumbar spine bone mineral density (BMD) >4% (adjusted for body mass index); 21 (10.6%) patients had decreases in total hip BMD >5% (adjusted for body mass index) Antiacne
04/18/2002 Advil Cold Suspension ibuprofen/ pseudoephedrine Temporary relief of nasal and sinus congestion, headache, stuffy nose, sore throat, minor aches and pains, and fever * Information on the over-the-counter use in pediatric patients 2 to 11 years of age Decongestant; anti-inflammatory
04/01/2002 Videx didanosine HIV infection * Safety and effectiveness established down to 2 weeks Antiviral
03/29/2002 Zerit stavudine HIV infection * Safety and effectiveness established down to birth * Established a dose for newborns from birth to 13 days Antiviral
02/14/2002 Mevacor lovastatin Heterozygous Familial Hypercholesterolemia * New indication in adolescent boys and girls (at least one year post-menarche) 10-17 years of age Antilipemic
02/08/2002 Clarinex Tablets desloratadine Relief of pruritis/hives in patients with chronic idiopathic urticaria * Approved down to 12 years of age Antihistamine
02/08/2002 Clarinex Tablets desloratadine Perennial allergic rhinitis * Approved down to 12 years of age Antihistamine
02/08/2002 Acular & Acular PF ketorolac Relief of ocular itching due to seasonal allergic rhinitis and postoperative inflammation after cataract extraction * Safety and effectiveness established down to 3 years; previously approved down to 12 years Anti-inflammatory
01/30/2002 Xopenex Inhalation Solution levalbuterol Treatment and prevention of bronchspasm * Approved down to 6 years of age; recommended dose is 0.31mg TID for patients 6-11 years of age Antiasthmatic
01/25/2002 Daypro oxaprozin Relief of signs and symptoms of Juvenile Rheumatoid Arthritis * New indication in 6 years -16 years Anti-inflammatory
12/28/2001 Rebetron; Rebetrol ribavirin/intron a; ribavirin Chronic hepatitis C * Labeling for 3 years to 16 years * There are no safety and efficacy data on treatment for longer than 48 weeks in pediatric patients * Pharmacokinetic information on patients 5 to 16 years with chronic hepatitis C virus infection * Increased incidence of suicidal ideation or attempts (2.4% versus 1%) among pediatric patients compared to adult patients * Decrease in rate of linear growth (mean percentile assignment decrease of 9%) and in rate of weight gain (mean percentile assignment decrease of 13%) during 48 weeks of treatment; a general reversal was noted during the 24 week post treatment period * Patients with viral genotype 1, had a lower response rate to combination therapy compared to patients with genotype non-1, 36% versus 81% * In general, the adverse event profile in the pediatric population was similar to that observed in adults * New oral suspension developed Antiviral
12/21/2001 Clarinex Tablets desloratadine Seasonal allergic rhinitis * Approved down to 12 years of age Antihistamine
12/20/2001 Alphagan brimonidine Prevention of post-operative IOP elevations * Safety and effectiveness established down to 2 years * Somnolence in patients 2 to 6 years (50-83%) versus patients 7 years of age or older (25%) Ophthalmologic hypotensive
12/13/2001 Elidel pimecrolimus Treatment of mild/moderate atopic dermatitis * Indicated for short-term and intermittent long-term therapy for mild to moderate atopic dermatitis in non-immunocompromised patients 2 years and older * Not recommended for use in pediatric patients less than 2 years of age. Infants on Elidel Cream had an increased incidence of some adverse events compared to vehicle which included pyrexia, URI, nasopharyngitis, gastroenteritis, otitis media, and diarrhea. Immunomodulator
11/16/2001 Calcijex calcitriol Management of hypocalcemia in patients undergoing chronic renal dialysis * The safety and effectiveness of calcitriol was examined in a double-blind placebo-controlled trial of 35 pediatric patients (13-18 years of age) with end-stage renal disease and on dialysis. * The primary efficacy endpoint favored the calcitriol-treated versus the placebo-treated patients * Transient hypercalcemia was seen in 1 of 16 calcitriol-treated patients; 6 of 16 (38%) calcitriol-treated patients and 2 of 19 (11%) placebo-treated patients had Ca x P >75 Vitamin
11/13/2001 Focalin dexmethylphenidate Attention Deficit Hyperactivity Disorder Pending CNS Stimulant
10/10/2001 Derma-Smoothe/FS Topical Oil fluocinolone Atopic dermatitis * Approved down to 2 years of age Anti-inflammatory, topical
10/03/2001 Diprolene AF, Diprosone, Lotrisone betamethason;betamethasone/ clotrimazole Diprolene AF and Diprosone - Relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses Lotrisone- Treatment of symptomatic inflammatory tinea pedis, tinea cruris and tinea corporis * Diprolene AF Cream * In an open-label study for the treatment of atopic dermatitis, 19 of 60 (32%) evaluable patients (ages 3 mo-12 years) showed HPA axis suppression. The younger the age group, the greater the proportion of patients with adrenal suppression. * Indicated in patients 13 years and older. Not recommended in pediatric patients 12 years and younger * Strengthened labeling in Clinical Pharmacology, Precautions- General and Pediatric Use subsections * Local adverse reactions including signs of skin atrophy (telengiectasia, bruising, shininess) occurred in 10% of pediatric patients (3mo-12 years) * Diprosone Cream, Ointment, Lotion * A separate open-label study was performed in pediatric patients with atopic dermatitis for each Diprosone formulation * Testing for HPA axis suppression was positive with each formulation in the age groups studied: Cream - 23% (ages 2yr-12yr); Ointment - 28% (ages 6mo-12yr); and Lotion - 73% (ages 6yr-12yr) * Indicated in patients 13 years and older. Not recommended in pediatric patients 12 years and younger * Strengthened labeling in Clinical Pharmacology, Precautions- General and Pediatric Use subsections * Local adverse reactions including signs of skin atrophy (telengiectasia, bruising, shininess) occurred in the cream and ointment studies * Lotrisone * Not recommended for patients under the age of 17 years and not recommended for diaper dermatitis; previously not recommended for patients under the age of 12 years * In an open-label study of Lotrisone cream for the treatment of tinea pedis, 17 of 43 (39.5%) evaluable patients (ages 12-16 years) demonstrated adrenal suppression as determined by cosyntropin testing * In an open-label study of Lotrisone cream for the treatment of tinea cruris, 8 of 17 (47.1%) evaluable patients (ages 12-16 years) demonstrated adrenal suppression by cosyntropin testing * Indicated in patients 17 years and older Anti-inflammatory, topical
10/01/2001 Betapace sotalol Arrhythmia * Analysis of 2 trials provided information on PK and PD in children 3 days  12 years; safety and efficacy have not been established * Information on dose, pharmacokinetics and AE's * Pharmacokinetics: BSA most important covariate and more relevant than age * Smaller children (BSA < 0.33 m2) showed tendency for larger change in QTc and increased frequency of prolongation of the QTc interval as well as greater beta-blocking effects * Individualized dosing on a mg/m2 basis * Information on preparation of a suspension Antiarrhythmic
08/28/2001 Topamax Tablets and Sprinkle Capsules topiramate Seizures associated with Lennox-Gastaut syndrome * Approved for treatment down to 2 years of age Anticonvulsant
08/16/2001 Epivir-HBV lamivudine Treatment of Chronic Hepatitis B * Safety and effectiveness established down to 2 years * Established a dose of 3mg/kg/day up to a maximum of 100mg/day (adult dose) Antiviral
07/19/2001 Buspar buspirone General Anxiety Disorder * Safety and effectiveness were not established in patients 6 to 17 years of age for treatment of General Anxiety Disorder at doses recommended for use in adults * PK parameters (AUC and Cmax) of buspirone and its active metabolite were found to be equal to or higher in children and adolescents than that of adults Antianxiety
06/25/2001 Valtrex Caplets valacyclovir Treatment of cold sores * New indication approved for use down to 12 years of age Antiviral
06/06/2001 Mentax Cream butenafine Tinea versicolor * Approved down to 12 years of age; previously approved in adults only Antifungal, topical
05/11/2001 Agenerase Capusles and Oral Solution amprenavir HIV * Approved for use in combination with other antiretroviral agents; new labeling provides information about the effects of drug-drug interaction Antiviral
03/30/2001 Ultane sevoflurane Induction and maintenance of general anesthesia * New study in pediatric patients 9 days-12 years comparing sevoflurane and halothane * Precautions section and Adverse Events During Post-Marketing subsection updated to add information on the rare cases of seizures that have been reported in pediatric patients in association with sevoflurane use. The majority of cases were in children and young adults, most of whom had no medical history of seizures * Pediatric information consolidated into new Pediatric Use subsection Anesthetic agent
03/27/2001 Nasalcrom cromolyn Prevention and relief of nasal symptoms of hay fever and other nasal allergies * Established proper dose in 2 year - 6 year olds and provided additional safety and compliance data for this age group Antiasthmatic
02/23/2001 Diprivan propofol Induction and/or maintenance of anesthesia * Maintenance of anesthesia- age decreased down to 2 months from 3 years * Induction of anesthesia remains the same- 3 years of age and above * Concomitant administration with fentanyl may result in serious bradycardia * Abrupt discontinuation following prolonged infusion may result in flushing of hands and feet, agitation, tremulousness and hyperirritability * Propofol is not indicated for pediatric ICU sedation as safety has not been established. In a single multicenter trial of ICU sedation in critically ill pediatric patients (patients with upper respiratory tract infections excluded), the incidence of mortality (causality not established) was 9% in the propofol arm versus 4% in the standard sedative agents arm Anesthetic agent
02/21/2001 Infuvite Pediatric multivitamin infusion Daily multivitamin maintenance * Approved for infants down to newborn Vitamin
02/13/2001 Vasotec enalapril Hypertension * Labeling for 1 month-16 years of age * Information on dose, efficacy and pharmacokinetics * Information on preparation of a suspension Antihypertensive
12/21/2000 Benzaclin benzoyl peroxide; clindamycin phosphate Acne vulgaris * Approved down to 12 years of age Antiacne, topical
12/20/2000 CellCept mycophenylate Prophylaxis of organ rejection in renal transplant patients * Approved for use down to 3 months of age as a combination regimen with cyclosporine and corticosteroids Immunosuppressant
12/15/2000 Glucophage (immediate release) metformin Diabetes Mellitus * Safety and effectiveness as monotherapy established in patients 10-16 years of age Antidiabetic
12/14/2000 TamiFlu oseltamivir Treatment of uncomplicated acute illness due to influenza * Safety and effectiveness established for treatment in patients 1-12 years of age * The safety and effectiveness in pediatric patients younger than 1 year of age have not been established * Safety and effectiveness for prophylaxis in pediatric patients younger than 13 years of age have not been established (Note: labeled for prophylaxis down to 1 year due to PREA on 12/21/2005) * The adverse event profile in adolescents is similar to that for adults and pediatric patients aged 1 to 12 years * Information on dosing, PK parameters, AE profile, and clinical studies Antiviral
12/11/2000 Maxalt and Maxalt-MLT rizatriptan Migraine *Su mmary is pending Antimigraine
12/08/2000 Protopic Ointment tacrolimus Atopic dermatitis * Approved down to 2 years of age; lower dose of 0.03% twice daily recommended for patients 2-15 years of age Immunomodulator
12/04/2000 Claritin loratadine Allergic rhinitis/Urticaria * Labeling for 2 - 5 year olds including information on dose, PK parameters and AE profile * PK parameter in 2-5 year olds given a 5mg dose was comparable to the 10mg dose in children 6 years to adolescence Antihistamine
11/27/2000 Benzamycin Pak erythromycin-benzoyl peroxide Acne vulgaris * Approved down to 12 years of age Antiacne, topical
11/27/2000 Clindagel clindamycin topical gel Acne vulgaris * Approved down to 12 years of age Antiacne, topical
11/17/2000 Tamiflu Capsule oseltamivir Prophylaxis of influenza A and B * Approved for prophylactic use down to 13 years of age Antiviral
11/14/2000 Trizivir Tablets abacavir, lamivudine, zidovudine HIV * Approved in adults and adolescents weighing e 40kg Antiviral
10/27/2000 Atrovent Nasal Spray ipratropium Rhinorrhea * Approved down to 5 years of age Antihistamine
10/12/2000 Neurontin gabapentin Adjunctive therapy in the treatment of partial seizures * Safety and effectiveness established down to 3 years * Neuropsychiatric AE's identified in 3-12 year olds * Oral clearance normalized per body weight increased in children <5 years * Higher doses of gabapentin required in children <5 years Anticonvulsant
09/29/2000 Flovent Diskus Inhalation Powder fluticasone Asthma * Approved down to 4 years of age; new delivery system Antiasthmatic
09/28/2000 Luvox fluvoxamine Treatment of obsessions and compulsions in patients with OCD * Determined that a dose adjustment (increased dose) may be necessary in adolescents and girls 8-11 years of age may require lower doses * FDA required boxed warning for all antidepressants: Suicidality in Children and Adolescents - Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in short-term studies in children and adolescents with Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of fluvoxamine or any other antidepressant in a child or adolescent must balance this risk with the clinical need. Patients who are started on therapy should be observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Fluvoxamine is not approved for use in pediatric patients except for patients with obsessive compulsive disorder (OCD). (See Warnings and Precautions: Pediatric Use) Pooled analyses of short-term (4 to 16 weeks) placebo-controlled trials of 9 antidepressant drugs (SSRIs and others) in children and adolescents with major depressive disorder (MDD), obsessive compulsive disorder (OCD), or other psychiatric disorders (a total of 24 trials involving over 4400 patients) have revealed a greater risk of adverse events representing suicidal thinking or behavior (suicidality) during the first few months of treatment in those receiving antidepressants. The average risk of such events in patients receiving antidepressants was 4%, twice the placebo risk of 2%. No suicides occurred in these trials * The efficacy of fluvoxamine for the treatment of OCD was demonstrated in a 10-week multicenter placebo controlled study with 120 outpatients ages 8 to 17. In addition, 99 of these outpatients continued open-label fluvoxamine treatment for up to another one to three years, equivalent to 94 patient years Antipsychotic
09/15/2000 QVAR beclomethasone dipropionate Maintenance treatment of asthma as prophylactic thrapy for asthma patients who require systemic corticosteroid administration Summary is pending Antiasthmatic
08/25/2000 Lac-Hydrin ammonium lactate Xerosis, ichthyosis * Safety and effectiveness established in patients 2  11 years of age; previously approved ³12 years of age Moisturizer
08/24/2000 Advair Diskus fluticasone/ salmeterol Asthma * Approved down to 12 years of age Antiasthmatic
08/21/2000 Unithroid Tablets levothyroxine Hypothyroidism * Approved down to the newborn Thyroid replacement
08/11/2000 Lodine XL etodolac Relief of signs & symptoms of Juvenile Rheumatoid Arthritis * New indication in 6 years -16 years * Higher dose (per kg basis) in younger children which is approximately 2 times the lower dose recommended for adults Anti-inflammatory
08/01/2000 Motrin Suspension ibuprofen/ pseudoephedrine Temporary relief of nasal and sinus congestion, minor body aches and pains, fever, stuffy nose, headache and sore throat * Information on the over-the-counter use in pediatric patients 2 to 11 years of age Decongestant; anti-inflammatory
08/01/2000 Concerta Extended Release Tablets methylphenidate ADHD * Efficacy established down to 6 years of age CNS Stimulant
07/27/2000 Vaniqa Cream eflornithine Reduction of facial hair in females * Approved for female patients down to 12 years of age Hair removal
07/14/2000 ChloraPrep OneStep OTC chlorhexidine/ isopropyl alcohol Skin preparation prior to surgery * New indication approved down to 2 months of age; Warning: do not use in less than 2 months of age Antiseptic
07/14/2000 Malarone atovaquone/ proguanil Treatment of malaria * Safety and efficacy for treatment of malaria established down to5 kg. * Attributable AE occurring in e 5% of the pediatric patients (5-< 11 kg) was diarrhea (6%) * Malarone tablets may be crushed and mixed with condensed milk just prior to administration for children who may have difficulty swallowing. * The apparent clearance (CL/F) of both atovaquone and proguanil are related to body weight Antimalarial
06/16/2000 AmBisome Injection amphotericin B Cryptococcal meningitis in HIV infected patients * New indication approved down to 1 year of age; established a dose of 6mg/kg/day Infectious disease (non-viral)
05/26/2000 Differin Cream adapalene Acne vulgaris * Approved down to 12 years of age Antiacne, topical
05/22/2000 Optivar azelastine Itching associated with Allergic Conjunctivitis * Safety and effectiveness established down to 3 years Antihistamine, topical
04/26/2000 Relenza Rotadisk zanamivir Treatment of Influenza A and B * Approved down to 7 years of age Antiviral
04/20/2000 Lantus insulin glargine Type 1 Diabetes * Safety and effectiveness established down to 6 years Antidiabetic
04/12/2000 Trivagizole 3 Vaginal Cream clotrimazole Vaginal yeast infection * Approved for OTC use in patients 12 years of age and older Antifungal, topical
04/04/2000 Humalog Injection insulin lispro Type 1 diabetes * Approved for use in the pediatric population; instructions on use of the diluted product in the pediatric population Antidiabetic
03/17/2000 Lamisil AT Spray Pump terbinafine Jock itch, athletes foot, ringworm * Approved for OTC use Antifungal, topical
02/04/2000 Tri-Nasal Spray triamcinolone Allergic rhinitis * Approved down to 12 years of age Anti-inflammatory, topical
01/12/2000 Advil ibuprofen Fever, minor aches & pain, cold symptoms * Extended age range from 2 years to 6 months for the over-the-counter use based on a large safety database (14,291 patients) Analgesic; Antipyretic
12/08/1999 Alocril nedocromil Allergic Conjunctivitis * Approved down to 3 years of age Antihistamine, topical
11/08/1999 Omnicef cefdinir Bronchitis * Approved for use in adolescents Antibiotic
10/22/1999 Zantac ranitidine Gastroesophageal Reflux * Small studies in newborns 0 to 1 month receiving ECMO did not demonstrate efficacy but provided information on dose and PK Antiulcerative
09/24/1999 Alamast pemirolast Allergic Conjunctivitis * Safety and effectiveness established down to 3 years Antihistamine, topical
09/17/1999 Accolate Tablets zafirlukast Prophylaxis and chronic treatment of asthma * Approved down to 7 years of age; efficacy extrapolated from demonstrated efficacy in patients 15 years and older Antiasthmatic
08/24/1999 Ceftin Oral Suspension cefuroxime Acute bacterial sinusitis * Approved down to 3 years of age Antibiotic
08/18/1999 Derma-Smoothe/FS Topical Oil fluocinolone Atopic dermatitis * Approved down to 6 years of age; previously approved in adults only Anti-inflammatory, topical
07/26/1999 Relenza Rotadisk zanamivir Treatment of influenza A and B * New indication approved down to 12 years of age Antiviral
07/23/1999 Topamax Tablets topiramate Adjunctive treatment of partial onset seizures and generalized tonic clonic seizures * Approved down to 2 years of age Anticonvulsant
07/14/1999 Omnicef cefdinir Otitis media * Approved 5-day treatment regimen; previously labeled for a 5-10 day treatment regimen Antibiotic
07/09/1999 Tagamet HB 200 Liquid OTC cimetidine Heartburn and indigestion * New indication approved down to 12 years of age; new OTC suspension Antiulcerative
07/02/1999 Zaditor Ophthalmic Soln. ketotifen fumarate Allergic conjunctivitis * Approved down to 3 years of age; efficacy extrapolated from adult data Antihistamine, topical
06/17/1999 Cutivate Cream fluticasone propionate Treatment of corticosteroid responsive dermatoses * Extended the age range from 5 years down to 3 months of age Anti-inflammatory, topical
04/15/1999 Motrin ibuprofen Fever, minor aches & pain, cold symptoms * Extended age range from 2 years to 6 months for the over-the-counter use based on a large safety database (27,000 patients) Analgesic; Antipyretic
12/17/1998 Ziagen abacavir HIV infection * Labeling for 3 months - 12 years * Information on dose, efficacy, PK parameters and AE profile Antiviral
10/15/1998 Versed midazolam Sedation/anxiolysis/ amnesia * Specified the effective dose, effective dose range, and time of onset * Defined volume of distribution and similarity to adult protein binding and elimination * Additional information on AE's and warnings about concomitant medications * Identified a subpopulation (children with congenital heart disease and pulmonary hypertension) at higher risk for AE's and the need to start therapy at the lower end of the dosing range Hypnotic
02/10/1998 Amerge naratriptan Migraine *Su mmary is pending Antimigraine

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Products in this table are listed by labeling change date in descending order and fell within the scope of the Pediatric Rule, the Best Pharmaceuticals for Children Act (BPCA), and the Pediatric Research Equity Act (PREA), and contain new pediatric information. All other labeling changes are based on information from clinical trials in pediatric patients. This list only serves to highlight key information affecting the pediatric population at the time the particular application was approved resulting from the studies performed for the Pediatric Rule, BPCA and PREA.

Helpful Links:
Drug and therapeutic biological labeling:
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

Biological labeling and reviews:
http://www.fda.gov/AboutFDA/CentersOffices/CBER/ucm122938.htm

BPCA 2002 Review Summaries:
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm161894.htm

**The Protopam labeling change is an exception. The labeling change is included in the Pediatric Labeling Changes Table even though it was not triggered by BPCA or PREA.

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