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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database

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N = 526
n = 477 with New Pediatric Studies; n = 49 with No New Pediatric Studies
BPCA only = 159; BPCA + PREA = 71; PREA only = 246; Rule = 49; None = 1

Pediatric Labeling Changes as of August 4,2014

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:  526
Pediatric Labeling Date Trade Name Generic Name or Proper Name (*) Indications Studied Label Changes Summary Therapeutic Category
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
04/11/2014 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
03/07/2014 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

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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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