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U.S. Department of Health and Human Services

Pediatric Studies Characteristics

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This table summarizes pediatric studies that led to FDAAA pediatric labeling changes pursuant to the Best Pharmaceuticals for Children Act, and the Pediatric Research Equity Act. CBER regulated products have an asterisk (*) by the proper name. To obtain all the information for a pediatric study, 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 product, enter the trade name or generic name in the Filter box and select Show Items.
Download Pediatric Studies Characteristics 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:  397
Approval Date Trade Name Generic or Proper Name (*) Indications Studied Therapeutic Category Study Type
03/19/2008 ARTISS Fibrin Sealant (Human)* To adhere autologous skin grafts to surgically prepared wound beds resulting from burns Wound healing Efficacy/Safety
03/14/2008 NovoLog insulin aspart [rDNA origin] injection Insulin analog indicated to improve glycemic control Antidiabetic Efficacy/Safety
03/14/2008 NovoLog insulin aspart [rDNA origin] injection Insulin analog indicated to improve glycemic control Antidiabetic Efficacy/Safety
03/12/2008 DAPTACEL Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed* Active immunization as a booster dose against diphtheria, tetanus & pertussis Preventive Vaccine Safety/Immunogenicity
02/27/2008 Nexium esomeprazole Short-term treatment of GERD Antiulcerative Efficacy/Safety
02/27/2008 Nexium esomeprazole Short-term treatment of GERD Antiulcerative Pharmacokinetic
02/21/2008 Humira adalimumab Treatment of juvenile idiopathic arthritis Anti-inflammatory Efficacy/Safety/Pharmacokinetic
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 Antiasthmatic Safety
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 Antiasthmatic Safety
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 Antiasthmatic Safety
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 Antiasthmatic Safety
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 Antiasthmatic Safety
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 Antiasthmatic Efficacy/Safety
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 Antiasthmatic Efficacy/Safety
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 Antiasthmatic Efficacy/Safety
01/31/2008 Inspra eplerenone Hypertension Antihypertensive Pharmacokinetic
01/31/2008 Inspra eplerenone Hypertension Antihypertensive Safety/Pharmacokinetic
01/31/2008 Inspra eplerenone Hypertension Antihypertensive Efficacy/Safety
01/23/2008 Moxatag amoxicillin Use for tonsillitis and/or pharyngitis secondary to Streptococcus pyogenes patients 12 years of age and older Antibiotic Efficacy/Safety
01/23/2008 Moxatag amoxicillin Use for tonsillitis and/or pharyngitis secondary to Streptococcus pyogenes patients 12 years of age and older Antibiotic Efficacy/Safety
01/10/2008 Alvesco Inhalation Aerosol, 80 mcg & 160 mcg ciclesonide Treatment of asthma in patients 12 years of age and older. Antiasthmatic Efficacy/Safety/Tolerability
01/10/2008 Alvesco Inhalation Aerosol, 80 mcg & 160 mcg ciclesonide Treatment of asthma in patients 12 years of age and older. Antiasthmatic Safety/Pharmacodynamic
01/10/2008 Alvesco Inhalation Aerosol, 80 mcg & 160 mcg ciclesonide Treatment of asthma in patients 12 years of age and older. Antiasthmatic Safety
01/10/2008 Alvesco Inhalation Aerosol, 80 mcg & 160 mcg ciclesonide Treatment of asthma in patients 12 years of age and older. Antiasthmatic Efficacy/Safety
01/10/2008 Alvesco Inhalation Aerosol, 80 mcg & 160 mcg ciclesonide Treatment of asthma in patients 12 years of age and older. Antiasthmatic Safety
01/10/2008 Alvesco Inhalation Aerosol, 80 mcg & 160 mcg ciclesonide Treatment of asthma in patients 12 years of age and older. Antiasthmatic Safety
01/10/2008 Alvesco Inhalation Aerosol, 80 mcg & 160 mcg ciclesonide Treatment of asthma in patients 12 years of age and older. Antiasthmatic Efficacy/Safety
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 Coagulant Efficacy/Safety
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 Coagulant Efficacy/Safety
12/27/2007 AndroGel testosterone Use in adolescent boys with delayed puberty Androgen-anabolic steroid Efficacy/Safety
12/27/2007 AndroGel testosterone Use in adolescent boys with delayed puberty Androgen-anabolic steroid Safety/Pharmacokinetic
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 Coagulant Efficacy/Safety
12/19/2007 Hepsera adefovir dipivoxil Chronic hepatitis B virus infection Antiviral Efficacy/Safety
12/19/2007 Hepsera adefovir dipivoxil Chronic hepatitis B virus infection Antiviral Safety/Pharmacokinetic
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 Anti-inflammatory, topical Safety
11/29/2007 Diovan valsartan Hypertension Antihypertensive Safety
11/29/2007 Diovan valsartan Hypertension Antihypertensive Pharmacokinetic
11/29/2007 Diovan valsartan Hypertension Antihypertensive Safety
11/21/2007 Omnaris Nasal Spray ciclesonide Treatment of seasonal allergic rhinitis (SAR) in patients 6 through less than 12 years of age Antihistamine Efficacy/Safety
11/21/2007 Omnaris Nasal Spray ciclesonide Treatment of seasonal allergic rhinitis (SAR) in patients 6 through less than 12 years of age Antihistamine Safety/Tolerability
10/29/2007 Abilify aripiprazole Schizophrenia Antipsychotic Pharmacokinetic
10/29/2007 Abilify aripiprazole Schizophrenia Antipsychotic Efficacy/Safety
10/29/2007 Abilify aripiprazole Schizophrenia Antipsychotic Efficacy/Safety
10/29/2007 Abilify aripiprazole Schizophrenia Antipsychotic Safety/Tolerability
09/28/2007 Lamisil Oral Granules terbinafine Tinea capitis Antifungal, topical Pharmacokinetic
09/28/2007 Lamisil Oral Granules terbinafine Tinea capitis Antifungal, topical Efficacy/Safety
09/28/2007 Lamisil Oral Granules terbinafine Tinea capitis Antifungal, topical Efficacy/Safety

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This information was extracted from various resources including the Medical and Clinical Pharmacology Reviews. Please note that there can be multiple numbers to describe each study, depending on the population of interest, including the number of patients randomized, enrolled, Intent to Treat (usually defined as the population of patients randomized that received at least one dose of study medication), modified Intend to Treat, and completed. Every effort is made to ensure the accuracy of this information. Data can only be provided if the information is provided by the sponsor. For instance, sponsor may report racial information using the categories suggested in the Guidance for Industry but they may use different categories. In addition, the ethnic data is not always provided for each study.

**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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