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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database

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N = 528
n = 479 with New Pediatric Studies; n = 49 with No New Pediatric Studies
BPCA only = 159; BPCA + PREA = 71; PREA only = 247; Rule = 50; 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:  528
Pediatric Labeling Date Trade Name Generic Name or Proper Name (*) Indications Studied Label Changes Summary Therapeutic Category
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 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
09/29/2006 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
09/28/2006 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
09/28/2006 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
09/27/2006 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

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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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