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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database

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N = 500
n = 453 with New Pediatric Studies; n = 47 with No New Pediatric Studies
BPCA only = 157; BPCA + PREA = 66; PREA only = 228; Rule = 48; None = 1

Pediatric Labeling Changes as of September 30, 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:  500
Pediatric Labeling Date Trade Name Generic Name or Proper Name (*) Indications Studied Label Changes Summary Therapeutic Category
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 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
04/27/2007 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
04/19/2007 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 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 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

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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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