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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database

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N = 523
n = 474 with New Pediatric Studies; n = 49 with No New Pediatric Studies
BPCA only = 158; BPCA + PREA = 70; PREA only = 244; Rule = 50; None = 1

Pediatric Labeling Changes as of July 15, 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:  523
Pediatric Labeling Date Trade Name Generic Name or Proper Name (*) Indications Studied Label Changes Summary Therapeutic Category
01/02/2008 EVICEL Fibrin Sealant (Human)* Adjunct to hemostasis for use in patients undergoing surgery, when control of bleeding by standard surgical techniques is ineffective or impractical See Package Insert for new information on biologics Coagulant
12/27/2007 AndroGel testosterone Use in adolescent boys with delayed puberty * Safety and efficacy in males < 18 years old have not been established * Improper use may result in acceleration of bone age and premature closure of epiphyses Androgen-anabolic steroid
12/27/2007 Voluven 6% Hydroxyethyl Starch 130/0.4 In 0.9% Sodium Chloride Injection* Plasma volume substitute for treatment and prophylaxis of hypovolemia See Package Insert for new information on biologics Coagulant
12/19/2007 Hepsera adefovir dipivoxil Chronic hepatitis B virus infection * Extended indication from adults to pediatric patients 12 years and older * Not recommended for children <12 years of age. Efficacy was not significantly different from placebo in a clinical study in children <12 years * Safety e12  < 18 years was similar to that observed in adults * Information on PK, AEs, clinical study, clinical resistance Antiviral
12/12/2007 Derma-Smoothe/FS Topical Oil fluocinolone Treatment of atopic dermatitis in pediatric patients 3 months and older for up to 4 weeks * Extended age range down to 3 months * Effectiveness and safety are not established in children less than 3 months old * Safety was evaluated in two pediatric clinical studies (including facial use) * Pediatric dosing and administration information provided * Studies waived in children under 3 months of age due to safety concerns of adrenal suppression * New indication Anti-inflammatory, topical
11/29/2007 Triesence 40mg/mL triamcinolone acetonide injectable suspension Visualization during vitrectomy * Efficacy and safety of corticosteroids in the pediatric population are based on the well-established course of effect of corticosteroids, which is similar in pediatric and adult populations * Adverse effects of corticosteroids in pediatric patients are similar to those in adults * New indication Anti-inflammatory, topical
11/29/2007 Diovan valsartan Hypertension * Labeling for 6-16 years of age * Not recommended for pediatric patients less than 6 years due to safety findings possibly related to treatment or with glomerular filtration rate < 30mL/min/1.73m2 * Information on dose, clinical studies in 1-16 years and pharmacokinetics * No relevant differences were identified between adverse experience profile for pediatric patients and that previously reported for adult patients * Information on preparation of a suspension Antihypertensive
11/21/2007 Omnaris Nasal Spray ciclesonide Treatment of seasonal allergic rhinitis (SAR) in patients 6 through less than 12 years of age * Indication extended down to 6 years of age * Pediatric dosing information provided * Two clinical studies evaluated safety in children 6 to 11 years of age and the overall incidence of adverse events was comparable to those treated with placebo * Efficacy in children 2 to 5 years of age was not established in clinical trials conducted in this age group. * Waiver of studies in children ages 0 to less than 2 years of age for SAR because of local and systemic safety concerns as well as lack of disease and/or diagnosis difficulties in children * New indication Antiasthmatic; antiallergy
11/09/2007 Kaletra Oral Solution, 80 mg/20 mg & Kaletra (1opinavir/ritonavir) Tablets, 200 mg/50 mg lopinavir/ ritonavir HIV -1 protease inibitor indicated in combination with other antiretroviral agents for the treatment of HIV -1 infection. * Dosing and administration information provided for children * Use of a lower strength tablet in a twice daily dosing regimen for pediatric patients weighing greater than 15 kg * New dosing regimen Antiviral
10/30/2007 Combigan 0.2%/0.5% ophthalmic solution brimonidine tartrate/timolol maleate Reduction of elevated intraocular pressure in patients with glaucoma or ocular hypertension * Safety and effectiveness supported by evidence from clinical studies in adults with additional data from a study in children with glaucoma ages 2  7 years old * Not recommended for use in children under the age of 2 years due to safety concerns based on reports of apnea, bradycardia, hypotension, hypothermia, hypotonia, and somnolence in infants * Safety and effectiveness have not been studied in children below the age of two years * New active ingredient Ophthalmologic hypotensive
10/29/2007 Abilify aripiprazole Schizophrenia * Extended schizophrenia indication from adults to adolescents 1317 years * Safety and effectiveness in pediatric patients with bipolar mania or agitation associated with schizophrenia or bipolar mania have not been established * Efficacy for the maintenance treatment of schizophrenia in the pediatric population has not been evaluated * In 6-week placebo controlled efficacy trial in patients 13  17 years with Schizophrenia 30 mg/day was not shown to be more efficacious than 10 mg/day * Common adverse events observed were extrapyramidal disorder, somnolence, and tremor; these 3 AEs appear to have a possible dose response relationship * Information on dose, AEs, clinical studies Antipsychotic
09/28/2007 Lamisil Oral Granules terbinafine Tinea capitis * New indication in 4 years and older * Two randomized safety and efficacy trials were conducted in patients 4 to 12 years old with tinea capitis. Terbinafine was dosed on a mg/kg basis and treated for 6 weeks * Although no hepatotoxicity was seen during trials, pre-treatment serum transaminases tests are advised. * The most common adverse events observed in the trials were nasopharyngitis, headache, pyrexia, cough, vomiting, and upper respiratory tract infection * New 125 mg and 187.5 mg oral granule formulations developed; take with food * Information on dose, PK parameters, AE profile, and instructions for use Antifungal, topical
09/20/2007 Norditropin Cartridges somatropin (rDNA origin) Treatment of short stature in children with Turner syndrome * Safety and effectiveness based on studies in pediatric patients * New Warning: Patients with Turner syndrome should be evaluated carefully for otitis media and other ear disorders since these patients have an increased risk of ear and hearing disorders. Somatropin treatment may increase the occurrence of otitis media in patients with Turner syndrome. In addition, patients with Turner syndrome should be monitored closely for cardiovascular disorders (e.g., stroke, aortic aneurysm/dissection, hypertension) as these patients are also at risk for these conditions * Information on recommended dosing, adverse events (AEs) and clinical studies * New indication Growth hormone
09/11/2007 Levaquin levofloxacin Community-acquired pneumonia * Levofloxacin is not indicated for pediatric patients < 18 years of age * In a prospective, long-term, surveillance study, levofloxacin treated children had a significantly higher incidence of musculoskeletal (MS) disorders (arthralgia, arthritis, tendonopathy, and gait abnormality) compared to non-fluoroquinolone-treated children * Information on clinical studies, AE profile Antibiotic
08/22/2007 Risperdal risperidone Schizophrenia; short-term treatment of acute manic or mixed Episodes associated with Bipolar I Disorder * Extended schizophrenia indication from adults to adolescents 1317 years; extended bipolar mania indication from adults to children and adolescents 10-17 years * Safety and effectiveness in children < 13 years of age with schizophrenia have not been established; safety and effectiveness in children < 10 years of age with bipolar mania have not been established * No additional benefit was seen above 3 mg/day in schizophrenia studies and 2.5 mg/day in the Bipolar mania study; higher doses were associated with more adverse events. Doses higher than 6 mg/day have not been studied. * Information on dose, clinical studies, AE profile Antipsychotic
08/17/2007 Provigil modafinil Narcolepsy * Modafinil is not approved for use in pediatric patients for any indication * Safety and effectiveness were not demonstrated in a controlled 6-week study in 165 pediatric patients 5-17 years with narcolepsy * Serious rash, including Stevens-Johnson Syndrome, requiring hospitalization and discontinuation of treatment has been reported in adults and children in association with the use of modafinil * In the controlled and open-label clinical studies, treatment emergent adverse events of the psychiatric and nervous system included Tourettes syndrome, insomnia, hostility, increased cataplexy, increased hypnagogic hallucinations and suicidal ideation * Information on safety, AEs and clinical study CNS Stimulant
08/16/2007 Zingo lidocaine Topical local analgesia prior to venipuncture or peripheral intravenous cannulation in children 3-18 years of age *Su mmary is pending Anesthetic, topical
07/18/2007 Toprol XL metoprolol Hypertension * A study in 144 pediatric hypertensive pediatric patients aged 6 - 16 years did not meet its primary endpoint. However, some study endpoints demonstrated effectiveness * Adverse event profile similar to adults * Safety and effectiveness have not been established in patients < 6 years of age * Information on PK parameters, clinical studies, and dose Antihypertensive
06/14/2007 Lexiva Oral Suspension fosamprenavir Treatment of HIV infection in patients 2-18 years of age * Effectiveness and safety were established in two clinical studies of pediatric patients 2-18 years of age * Adverse event profile is similar to that of adults with the exception of vomiting, which, regardless of causality, occurred more frequently among pediatric patients * Dosing information provided * Studies waived in children 0-1 month of age and deferred in children 1 month - 2 years of age * New dosage form Antiviral
06/12/2007 Extina Foam, 2% ketoconazole Topical treatment of seborrheic dermatitis in immunocompetent patients 12 years of age and older * Effectiveness and safety were established in a clinical study that included 44 patients from 12-17 years of age * Studies waived in children 0-12 years of age * New dosage form Antifungal, topical
06/08/2007 Betoptic S betaxolol Elevated intraocular pressure in patients with chronic open-angle glaucoma or ocular hypertension * Extended indication from adults to pediatric patients * The adverse reaction profile was comparable to that seen in adults Ophthalmologic hypotensive
06/08/2007 Timolol GFS timolol Elevated intraocular pressure in patients with chronic open-angle glaucoma or ocular hypertension * Extended indication from adults to pediatric patients * The adverse reaction profile was comparable to that seen in adults Ophthalmologic hypotensive
05/30/2007 Zyflo CR Extended Release Tablets zileuton Prevention and chronic treatment of asthma in children 12 years of age and older * Should not be used in children under 12 years of age * Effectiveness was established in clinical studies that included pediatric patients 12 years of age and older * Short-term and long-term safety were established in clinical studies that included pediatric patients 12 years of age and older * Studies waived in children 0-4 years of age and deferred in children 5-11 years of age * New dosage form Antiasthmatic
05/25/2007 Xyzal Tablets 5 mg levocetirizine Relief of symptoms associated with seasonal allergic rhinitis and perennial allergic rhinitis in adults and children 6 years of age or older, and for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 years of age or older *Su mmary is pending Antihistamine
05/18/2007 Locoid Lotion 0.1% hydrocortisone butyrate Treatment of mild to moderate atopic dermatitis in children 3 months of age and older * Effectiveness established in one study of 284 patients from 3 months to 18 years of age * Information provided on HPA axis suppression from one safety study with Locoid Lotion of 84 pediatric patients from 3 months to 18 years of age with moderate to severe atopic dermatitis affecting at least 25% of body surface area * Studies waived in children < 3 months of age * New dosage form Anti-inflammatory, topical
04/27/2007 Azasite Ophthalmic Solution 1% azithromycin Treatment of bacterial conjunctivitis caused by certain microorganisms in patients down to 1 year of age * Effectiveness and safety were established in controlled clinical trials including patients down to 1 years of age * Dosing information provided * New dosage form Antibiotic
04/27/2007 Veramyst fluticasone furoate Treatment of the symptoms of seasonal and perennial allergic rhinitis *Approved in patients 2 years and older * Controlled clinical trials included 1,224 patients 2 - 11 years and 344 adolescent patients 12 to 17 years* The safety and effectiveness in children < 2 years have not been established* Information on clinical trials, dosing, and adverse reactions*New drug Anti-inflammatory, topical
04/19/2007 Valtropin somatropin (rDNA origin) Short stature in children with Turner Syndrome *Su mmary is pending Growth hormone
04/12/2007 Altabax Ointment 1% retapamulin Treatment of impetigo in patients 9 months of age and older * Safety and effectiveness established in studies that included 588 pediatric patients from 9 months of age to 17 years of age * Studies waived in children 0-2 months of age and deferred in children 2-9 months of age * New active ingredient Antibiotic, topical
03/28/2007 Ambien zolpidem Insomnia associated with ADHD * Safety and effectiveness have not been established in pediatric patients with insomnia associated with ADHD * In an 8-week controlled study in 201 pediatric patients 6-17 years, psychiatric and nervous system disorders comprised > 5% of treatment emergent adverse events, including dizziness (23.5%) headache (12.5%) and hallucinations (7.4%); treatment was discontinued due to an adverse event in 7.4% Hypnotic
03/22/2007 Aldara imiquimod Molluscum contagiosum * Efficacy in patients 2  12 years for the treatment of molluscum contagiosum was not demonstrated in two clinical trials in 702 patients * Information on clinical studies and AEs Topical
03/19/2007 Keppra Tablets/ Keppra Oral Solution levetiracetam Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in children 6 years of age and older with idiopathic generalized epilepsy * Safety and effectiveness established in study that included patients down to 4 years of age * Pediatric dosing information added * Studies waived in children 1 month to 2 years of age and deferred in children 2-6 years of age * New indication Anticonvulsant
02/23/2007 Coreg carvedilol Heart failure * Effectiveness has not been established in patients < 18 years * In a double-blind trial of 161 children, 2 months to 17 years with chronic heart failure receiving standard background treatment, randomized to placebo or carvedilol, carvedilol demonstrated reduction of heart rate 4-6 beats per minute * There was no significant effect of treatment on clinical outcomes after 8 months of follow-up * AEs occurring in e 10% of patients treated with carvedilol included chest pain (17%), dizziness (13%), and dyspnea (11%) Antihypertensive
02/23/2007 Vyvanse Capsules lisdexamfetamine Treatment of ADHD in children 6 to 12 years of age * Effectiveness established in two studies of patients 6-12 years of age * Long-term effectiveness of more than 4 weeks has not been established * Studies waived in children 0-5 years of age and deferred in children 13-17 years of age * New active ingredient CNS Stimulant
02/07/2007 Actiq fentanyl Treatment of breakthrough pain in opioid tolerant children * Safety and efficacy in patients below the age of 16 years was not established in a clinical trial of 15 patients 5 to 15 years * Information on PK parameters and clinical studies Anesthetic agent
01/10/2007 Eloxatin oxaliplatin Solid tumors * The effectiveness of oxaliplatin in children has not been established * No significant activity observed in 2 Phase I and 2 Phase II trials in 159 patients ages 7 months to 22 years with solid tumors * Information on clinical studies and AEs Antineoplastic
12/22/2006 Emtriva emtricitabine HIV-1 infection in combination with other antiretroviral agents * Efficacy in preventing or treating HIV in neonates to 3 month olds could not be determined after a PK study in 20 neonates born to HIV positive mothers * Information on dose in 0-3 months, additional safety and PK parameters Antiviral
12/20/2006 Colazal balsalazide Mildly to moderately active ulcerative colitis in patients 5 years of age and older * Extended indication from adults to patients 5 years and older * Dosing can be initiated at either 6.75 or 2.25 g/day * PK of balsalazide, and metabolites showed very large inter-patient variability similar to that seen in adults * AEs were similar to those seen in adults Gastroenterology
12/15/2006 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
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
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

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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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