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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
06/20/2008 Pentacel Diphtheria And Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus B Conjugate (Tetanus Toxoid Conjugate) Vaccine* Active immunization against diphtheria, tetanus, pertussis, poliomyelitis and invasive disease due to Haemophilus influenzae type b Preventive Vaccine Safety/Immunogenicity
06/05/2008 Zetia and Vytorin ezetimibe and ezetimibe/ simvastatin Heterozygous familial hypercholesterolemia as an adjunct to diet Antilipemic Efficacy/Safety
05/09/2008 OraVerse Injection 0.4 mg (0.235 mg/mL) phentolamine mesylate Reversal of soft-tissue anesthesia, i.e., anesthesia of the lip and tongue, and the associated functional deficits resulting from an intraoral submucosal injection of a local anesthetic containing a vasoconstrictor Anesthetic, topical Efficacy/Safety/Pharmacodynamic
05/09/2008 OraVerse Injection 0.4 mg (0.235 mg/mL) phentolamine mesylate Reversal of soft-tissue anesthesia, i.e., anesthesia of the lip and tongue, and the associated functional deficits resulting from an intraoral submucosal injection of a local anesthetic containing a vasoconstrictor Anesthetic, topical Efficacy/Safety/Pharmacodynamic
05/09/2008 OraVerse Injection 0.4 mg (0.235 mg/mL) phentolamine mesylate Reversal of soft-tissue anesthesia, i.e., anesthesia of the lip and tongue, and the associated functional deficits resulting from an intraoral submucosal injection of a local anesthetic containing a vasoconstrictor Anesthetic, topical Efficacy/Safety
05/09/2008 OraVerse Injection 0.4 mg (0.235 mg/mL) phentolamine mesylate Reversal of soft-tissue anesthesia, i.e., anesthesia of the lip and tongue, and the associated functional deficits resulting from an intraoral submucosal injection of a local anesthetic containing a vasoconstrictor Anesthetic, topical Efficacy/Safety
05/09/2008 OraVerse Injection 0.4 mg (0.235 mg/mL) phentolamine mesylate Reversal of soft-tissue anesthesia, i.e., anesthesia of the lip and tongue, and the associated functional deficits resulting from an intraoral submucosal injection of a local anesthetic containing a vasoconstrictor Anesthetic, topical Safety/Pharmacokinetic
05/08/2008 Desmopressin acetate Tablets, 0.1 mg and 0.2 mg desmopressin acetate Determine the capacity of the kidney to concentrate urine in pediatric patients (Renal Concentration Capacity Test or RCCT) and management of primary nocturnal enuresis (PNE) Urology Efficacy/Safety
05/08/2008 Desmopressin acetate Tablets, 0.1 mg and 0.2 mg desmopressin acetate Determine the capacity of the kidney to concentrate urine in pediatric patients (Renal Concentration Capacity Test or RCCT) and management of primary nocturnal enuresis (PNE) Urology Efficacy/Safety
05/08/2008 Desmopressin acetate Tablets, 0.1 mg and 0.2 mg desmopressin acetate Determine the capacity of the kidney to concentrate urine in pediatric patients (Renal Concentration Capacity Test or RCCT) and management of primary nocturnal enuresis (PNE) Urology Efficacy
05/08/2008 Desmopressin acetate Tablets, 0.1 mg and 0.2 mg desmopressin acetate Determine the capacity of the kidney to concentrate urine in pediatric patients (Renal Concentration Capacity Test or RCCT) and management of primary nocturnal enuresis (PNE) Urology Efficacy
05/08/2008 Desmopressin acetate Tablets, 0.1 mg and 0.2 mg desmopressin acetate Determine the capacity of the kidney to concentrate urine in pediatric patients (Renal Concentration Capacity Test or RCCT) and management of primary nocturnal enuresis (PNE) Urology Efficacy
05/08/2008 Desmopressin acetate Tablets, 0.1 mg and 0.2 mg desmopressin acetate Determine the capacity of the kidney to concentrate urine in pediatric patients (Renal Concentration Capacity Test or RCCT) and management of primary nocturnal enuresis (PNE) Urology Efficacy
05/08/2008 Desmopressin acetate Tablets, 0.1 mg and 0.2 mg desmopressin acetate Determine the capacity of the kidney to concentrate urine in pediatric patients (Renal Concentration Capacity Test or RCCT) and management of primary nocturnal enuresis (PNE) Urology Efficacy
05/05/2008 Argatroban argatroban Heparin-Induced Thrombocytopenia (HIT) or HIT with Thrombosis Hematology/Coagulation Efficacy/Safety/Pharmacokinetic/Pharmacodynamic
04/30/2008 Cardiolite technetium tc99m sestamibi Medical imaging in Kawasaki disease Diagnostic aid Safety/Pharmacokinetic
04/30/2008 Cardiolite technetium tc99m sestamibi Medical imaging in Kawasaki disease Diagnostic aid Efficacy/Safety
04/30/2008 Cardiolite technetium tc99m sestamibi Medical imaging in Kawasaki disease Diagnostic aid Efficacy/Safety
04/15/2008 Patanase Nasal Spray olopatadine hydrochloride Relief of symptoms of seasonal allergic rhinitis (SAR) in patients 12 years of age and older Antihistamine Efficacy/Safety
04/15/2008 Patanase Nasal Spray olopatadine hydrochloride Relief of symptoms of seasonal allergic rhinitis (SAR) in patients 12 years of age and older Antihistamine Efficacy/Safety
04/15/2008 Patanase Nasal Spray olopatadine hydrochloride Relief of symptoms of seasonal allergic rhinitis (SAR) in patients 12 years of age and older Antihistamine Safety
04/15/2008 Patanase Nasal Spray olopatadine hydrochloride Relief of symptoms of seasonal allergic rhinitis (SAR) in patients 12 years of age and older Antihistamine Efficacy/Safety
04/15/2008 Patanase Nasal Spray olopatadine hydrochloride Relief of symptoms of seasonal allergic rhinitis (SAR) in patients 12 years of age and older Antihistamine Efficacy/Safety
04/15/2008 Patanase Nasal Spray olopatadine hydrochloride Relief of symptoms of seasonal allergic rhinitis (SAR) in patients 12 years of age and older Antihistamine Efficacy/Safety
04/15/2008 Patanase Nasal Spray olopatadine hydrochloride Relief of symptoms of seasonal allergic rhinitis (SAR) in patients 12 years of age and older Antihistamine Efficacy
04/15/2008 Patanase Nasal Spray olopatadine hydrochloride Relief of symptoms of seasonal allergic rhinitis (SAR) in patients 12 years of age and older Antihistamine Efficacy/Safety/Pharmacokinetic
04/15/2008 Patanase Nasal Spray olopatadine hydrochloride Relief of symptoms of seasonal allergic rhinitis (SAR) in patients 12 years of age and older Antihistamine Safety
04/15/2008 Patanase Nasal Spray olopatadine hydrochloride Relief of symptoms of seasonal allergic rhinitis (SAR) in patients 12 years of age and older Antihistamine Efficacy/Safety
04/07/2008 Orencia abatacept Moderate to severe polyarticular juvenile idiopathic arthritis Anti-inflammatory Efficacy/Safety
04/03/2008 ROTARIX Rotavirus Vaccine, Live, Oral* Prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9) Preventive Vaccine Efficacy/Safety/Immunogenicity
04/03/2008 ROTARIX Rotavirus Vaccine, Live, Oral* Prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9) Preventive Vaccine Safety/Immunogenicity
04/03/2008 ROTARIX Rotavirus Vaccine, Live, Oral* Prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9) Preventive Vaccine Efficacy/Safety/Immunogenicity
04/03/2008 ROTARIX Rotavirus Vaccine, Live, Oral* Prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9) Preventive Vaccine Efficacy/Safety/Immunogenicity
04/03/2008 ROTARIX Rotavirus Vaccine, Live, Oral* Prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9) Preventive Vaccine Safety/Immunogenicity
04/03/2008 ROTARIX Rotavirus Vaccine, Live, Oral* Prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9) Preventive Vaccine Efficacy/Safety/Immunogenicity
04/03/2008 ROTARIX Rotavirus Vaccine, Live, Oral* Prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9) Preventive Vaccine Safety/Immunogenicity
04/03/2008 ROTARIX Rotavirus Vaccine, Live, Oral* Prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9) Preventive Vaccine Safety/Immunogenicity
03/31/2008 Lancôme UV Expert 40 La Roche-Posay Anthelios 40 Vichy Capital Soleil 40 avobenzone, ecamsule, octocrylene, titanium dioxide cream Sunscreen OTC Sunscreen Safety
03/26/2008 Ventolin HFA albuterol Treatment of symptoms of bronchospasm associated with obstructive airway disease Antiasthmatic Efficacy/Safety
03/26/2008 Ventolin HFA albuterol Treatment of symptoms of bronchospasm associated with obstructive airway disease Antiasthmatic Efficacy/Safety
03/26/2008 Ventolin HFA albuterol Treatment of symptoms of bronchospasm associated with obstructive airway disease Antiasthmatic Efficacy/Safety
03/25/2008 Reyataz atazanavir HIV in 6 years and older Antiviral Safety/Pharmacokinetic
03/24/2008 Depakote ER Depakote Sprinkles divalproex disodium Pediatric Bipolar Disorder; Prophylaxis of Migraine Anticonvulsant; Mood Stablizer Efficacy/Safety
03/24/2008 Depakote ER Depakote Sprinkles divalproex disodium Pediatric Bipolar Disorder; Prophylaxis of Migraine Anticonvulsant; Mood Stablizer Efficacy
03/24/2008 Depakote ER Depakote Sprinkles divalproex disodium Pediatric Bipolar Disorder; Prophylaxis of Migraine Anticonvulsant; Mood Stablizer Safety
03/20/2008 Prilosec omeprazole Maintenance healing of erosive esophagitis Antiulcerative Pharmacokinetic
03/20/2008 Prilosec omeprazole Maintenance healing of erosive esophagitis Antiulcerative Efficacy
03/20/2008 Prilosec omeprazole Maintenance healing of erosive esophagitis Antiulcerative Pharmacokinetic
03/20/2008 Zometa zoledronic acid Severe osteogenesis imperfecta Bone density Pharmacokinetic
03/20/2008 Zometa zoledronic acid Severe osteogenesis imperfecta Bone density 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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