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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database
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N = 470
n = 428 with New Pediatric Studies; n = 42 with No New Pediatric Studies
BPCA only = 153; BPCA + PREA = 63; PREA only = 205; Rule = 48; None = 1

Pediatric Labeling Changes as of May 21, 2013

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:  471
Pediatric Labeling Date Trade Name Generic Name or Proper Name (*) Indications Studied Label Changes Summary Therapeutic Category
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

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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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