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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.
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   No. of Records Found:  397
Approval Date Trade Name Generic or Proper Name (*) Indications Studied Therapeutic Category Study Type
09/28/2010 Kapvay Extended Release Tablets clonidine Treatment of attention deficit hyperactivity disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications Non-stimulant ADHD treatment Efficacy/Safety
09/28/2010 Kapvay Extended Release Tablets clonidine Treatment of attention deficit hyperactivity disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications Non-stimulant ADHD treatment Safety
08/27/2010 Augmentin XR amoxicillin/clavulanate potassium Community-acquired pneumonia or acute bacterial sinusitis Antibiotic Pharmacokinetic
07/28/2010 Lastacaft Ophthalmic Solution alcaftadine Prevention of itching associated with allergic conjunctivitis. Antihistamine, topical Efficacy/Safety
07/28/2010 Lastacaft Ophthalmic Solution alcaftadine Prevention of itching associated with allergic conjunctivitis. Antihistamine, topical Efficacy/Safety
07/28/2010 Lastacaft Ophthalmic Solution alcaftadine Prevention of itching associated with allergic conjunctivitis. Antihistamine, topical Safety
07/28/2010 Lastacaft Ophthalmic Solution alcaftadine Prevention of itching associated with allergic conjunctivitis. Antihistamine, topical Efficacy/Safety
07/28/2010 Lastacaft Ophthalmic Solution alcaftadine Prevention of itching associated with allergic conjunctivitis. Antihistamine, topical Efficacy/Safety
06/29/2010 Daytrana methylphenidate ADHD CNS Stimulant Safety
06/29/2010 Daytrana methylphenidate ADHD CNS Stimulant Efficacy/Safety
06/29/2010 Daytrana methylphenidate ADHD CNS Stimulant Pharmacokinetic
06/22/2010 Dulera Inhalation Aerosol mometasone furoate and formoterol fumarate Asthma Antiasthmatic Efficacy/Safety
06/22/2010 Dulera Inhalation Aerosol mometasone furoate and formoterol fumarate Asthma Antiasthmatic Efficacy/Safety
06/22/2010 Dulera Inhalation Aerosol mometasone furoate and formoterol fumarate Asthma Antiasthmatic Efficacy/Safety
06/22/2010 Dulera Inhalation Aerosol mometasone furoate and formoterol fumarate Asthma Antiasthmatic Safety
06/22/2010 Dulera Inhalation Aerosol mometasone furoate and formoterol fumarate Asthma Antiasthmatic Efficacy/Safety
06/22/2010 Dulera Inhalation Aerosol mometasone furoate and formoterol fumarate Asthma Antiasthmatic Efficacy/Safety
06/03/2010 Zylet loteprednol etabonate and tobramycin Eye lid inflammation Anti-inflammatory, Antibiotic Efficacy/Safety
05/26/2010 Nasonex mometasone Nasal congestion associated with seasonal allergic rhinitis Anti-inflammatory, topical Efficacy
05/26/2010 Nasonex mometasone Nasal congestion associated with seasonal allergic rhinitis Anti-inflammatory, topical Efficacy
05/26/2010 Nasonex mometasone Nasal congestion associated with seasonal allergic rhinitis Anti-inflammatory, topical Efficacy
05/18/2010 Zymaxid gatifloxacin Bacterial conjunctivitis Antibiotic Efficacy/Safety
05/18/2010 Zymaxid gatifloxacin Bacterial conjunctivitis Antibiotic Efficacy/Safety
05/13/2010 Taxotere docetaxel Solid Tumors Antineoplastic Pharmacokinetic/Tolerability
05/13/2010 Taxotere docetaxel Solid Tumors Antineoplastic Efficacy/Safety
05/13/2010 Taxotere docetaxel Solid Tumors Antineoplastic Efficacy/Safety
04/12/2010 Pancreaze pancrelipase Treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions Pancreatic enzyme Efficacy/Safety/Tolerability
04/12/2010 Pancreaze pancrelipase Treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions Pancreatic enzyme Efficacy/Safety
03/24/2010 Viread tenofovir disoproxil fumarate Treatment of HIV infection in combination with other antiretroviral agents Antiviral Efficacy/Safety
03/17/2010 Differin Lotion adapalene Acne Antiacne, topical Efficacy/Safety
03/17/2010 MultiHance Injection gadobenate dimeglumine Intravenous use in magnetic resonance imaging Diagnostic aid Safety/Pharmacokinetic
03/17/2010 MultiHance Injection gadobenate dimeglumine Intravenous use in magnetic resonance imaging Diagnostic aid Efficacy/Safety
03/17/2010 Differin Lotion adapalene Acne Antiacne, topical Efficacy/Safety
02/24/2010 Prevnar 13 Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein) * Active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F, and for the prevention of otitis media caused by serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F Preventive Vaccine Safety/Immunogenicity
02/24/2010 Prevnar 13 Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein) * Active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F, and for the prevention of otitis media caused by serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F Preventive Vaccine Safety/Tolerability/Immunogenicity
02/24/2010 Prevnar 13 Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein) * Active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F, and for the prevention of otitis media caused by serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F Preventive Vaccine Safety/Tolerability/Immunogenicity
02/24/2010 Prevnar 13 Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein) * Active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F, and for the prevention of otitis media caused by serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F Preventive Vaccine Safety/Immunogenicity
02/24/2010 Prevnar 13 Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein) * Active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F, and for the prevention of otitis media caused by serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F Preventive Vaccine Safety/Immunogenicity
02/22/2010 TamiFlu oseltamivir Prophylaxis of influenza Antiviral Efficacy/Safety
02/19/2010 MENVEO Meningococcal (Groups A, C, Y, and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine* Active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135 Preventive Vaccine Safety/Immunogenicity
02/19/2010 MENVEO Meningococcal (Groups A, C, Y, and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine* Active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135 Preventive Vaccine Safety/Immunogenicity
02/19/2010 MENVEO Meningococcal (Groups A, C, Y, and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine* Active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135 Preventive Vaccine Safety/Immunogenicity
02/19/2010 MENVEO Meningococcal (Groups A, C, Y, and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine* Active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135 Preventive Vaccine Safety/Immunogenicity
02/04/2010 Benicar olmesartan Hypertension Antihypertensive Pharmacokinetic
02/04/2010 Benicar olmesartan Hypertension Antihypertensive Efficacy/Safety/Pharmacokinetic
01/29/2010 Lamictal XR lamotrigine Adjunctive therapy for Primary Generalized Tonic-Clonic seizures Anticonvulsant Efficacy/Safety/Pharmacokinetic
01/04/2010 Xolair omalizumab Moderate to severe persistent asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids. Antiasthmatic Safety/Tolerability
01/04/2010 Xolair omalizumab Moderate to severe persistent asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids. Antiasthmatic Efficacy/Safety/Pharmacokinetic/Pharmacodynamic
12/24/2009 Famvir famciclovir Treatment of children 1 month  12 years of age w/ herpes simplex (HSV) & 1  12 years w/ varicella zoster (VSV) Antiviral Safety/Pharmacokinetic
12/24/2009 Famvir famciclovir Treatment of children 1 month  12 years of age w/ herpes simplex (HSV) & 1  12 years w/ varicella zoster (VSV) Antiviral Safety/Pharmacokinetic

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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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