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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
08/31/2009 Astepro Nasal Spray azelastine hydrochloride Seasonal and perennial allergic rhinitis in patients 12 years of age and older. Antihistamine Efficacy/Safety
08/31/2009 Astepro Nasal Spray azelastine hydrochloride Seasonal and perennial allergic rhinitis in patients 12 years of age and older. Antihistamine Safety/Tolerability
08/28/2009 Valcyte valganciclovir Prevention of cytomegalovirus (CMV) disease in pediatric kidney and heart transplant patients e 4 months of age Antiviral Safety/Pharmacokinetic/Tolerability
08/28/2009 Valcyte valganciclovir Prevention of cytomegalovirus (CMV) disease in pediatric kidney and heart transplant patients e 4 months of age Antiviral Pharmacokinetic/Pharmacodynamic
08/28/2009 Valcyte valganciclovir Prevention of cytomegalovirus (CMV) disease in pediatric kidney and heart transplant patients e 4 months of age Antiviral Safety/Pharmacokinetic
08/28/2009 Valcyte valganciclovir Prevention of cytomegalovirus (CMV) disease in pediatric kidney and heart transplant patients e 4 months of age Antiviral Safety/Pharmacokinetic
08/27/2009 Zenpep pancrelipase Exocrine pancreatic insufficiency due to cystic fibrosis Pancreatic enzyme Efficacy/Safety
08/27/2009 Zenpep pancrelipase Exocrine pancreatic insufficiency due to cystic fibrosis Pancreatic enzyme Efficacy/Safety
08/21/2009 Xyzal levocetirizine dihydrochloride Seasonal allergic rhinitis (SAR) in children 2 years of age and older; perennial allergic rhinitis (PAR) and chronic idiopathic urticaria (CIU) for children 6 months of age and older Antihistamine Pharmacokinetic
08/21/2009 Xyzal levocetirizine dihydrochloride Seasonal allergic rhinitis (SAR) in children 2 years of age and older; perennial allergic rhinitis (PAR) and chronic idiopathic urticaria (CIU) for children 6 months of age and older Antihistamine Safety
08/21/2009 Xyzal levocetirizine dihydrochloride Seasonal allergic rhinitis (SAR) in children 2 years of age and older; perennial allergic rhinitis (PAR) and chronic idiopathic urticaria (CIU) for children 6 months of age and older Antihistamine Safety
08/19/2009 HIBERIX Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) * Active immunization as a booster dose for the prevention of invasive disease caused by Haemophilus influenzae type b Preventive Vaccine Immunogenicity
08/19/2009 HIBERIX Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) * Active immunization as a booster dose for the prevention of invasive disease caused by Haemophilus influenzae type b Preventive Vaccine Immunogenicity
08/19/2009 HIBERIX Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) * Active immunization as a booster dose for the prevention of invasive disease caused by Haemophilus influenzae type b Preventive Vaccine Safety
08/19/2009 HIBERIX Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) * Active immunization as a booster dose for the prevention of invasive disease caused by Haemophilus influenzae type b Preventive Vaccine Immunogenicity
07/31/2009 Xerese acyclovir/ hydrocortisone Recurrent herpes labialis (cold sores) in 12 years of age and older Antiviral, topical Safety
07/23/2009 Actonel risedronate Osteogenesis imperfecta Bone density Safety/Pharmacokinetic/Tolerability
07/23/2009 Actonel risedronate Osteogenesis imperfecta Bone density Efficacy/Safety
06/18/2009 Nexium esomeprazole Short-term treatment of GERD Antiulcerative Safety/Pharmacokinetic/Pharmacodynamic
06/18/2009 Nexium esomeprazole Short-term treatment of GERD Antiulcerative Safety/Pharmacokinetic/Pharmacodynamic
06/18/2009 Nexium esomeprazole Short-term treatment of GERD Antiulcerative Efficacy/Safety
05/29/2009 Lamictal XR lamotrigine Adjunctive therapy for partial onset seizures in patients e13 years of age Anticonvulsant Efficacy/Safety/Pharmacokinetic/Tolerability
05/28/2009 Besivance besifloxacin ophthalmic suspension Treatment of bacterial conjunctivitis Antibiotic, topical Efficacy/Safety
05/28/2009 Besivance besifloxacin ophthalmic suspension Treatment of bacterial conjunctivitis Antibiotic, topical Efficacy/Safety
05/28/2009 Besivance besifloxacin ophthalmic suspension Treatment of bacterial conjunctivitis Antibiotic, topical Efficacy/Safety
05/08/2009 Lamictal lamotrigine Adjunctive treatment for partial seizures in pediatric patients 1  24 months Anticonvulsant Efficacy/Safety/Pharmacokinetic
05/08/2009 Lamictal lamotrigine Adjunctive treatment for partial seizures in pediatric patients 1  24 months Anticonvulsant Safety
05/01/2009 Cetraxal ciprofloxacin otic solution Treatment of acute otitis externa due to susceptible isolates of Pseudomonas aeruginosa or Staphylococcus aureus Antibiotic, topical Efficacy/Safety
04/30/2009 Axert almotriptan Acute treatment of pediatric migraine in adolescent patients age 12-17 years Antimigraine Efficacy
04/30/2009 Axert almotriptan Acute treatment of pediatric migraine in adolescent patients age 12-17 years Antimigraine Safety
04/30/2009 Creon pancrelipase Exocrine pancreatic insufficiency due to cystic fibrosis or other conditions Pancreatic enzyme Efficacy/Safety
04/30/2009 Creon pancrelipase Exocrine pancreatic insufficiency due to cystic fibrosis or other conditions Pancreatic enzyme Efficacy/Safety/Tolerability
04/30/2009 Creon pancrelipase Exocrine pancreatic insufficiency due to cystic fibrosis or other conditions Pancreatic enzyme Efficacy/Safety
04/09/2009 Ulesfia Lotion, 5% benzyl alcohol Treatment of head lice Pediculocide, topical Efficacy/Safety
04/09/2009 Ulesfia Lotion, 5% benzyl alcohol Treatment of head lice Pediculocide, topical Efficacy/Safety
04/09/2009 Ulesfia Lotion, 5% benzyl alcohol Treatment of head lice Pediculocide, topical Efficacy
04/09/2009 Ulesfia Lotion, 5% benzyl alcohol Treatment of head lice Pediculocide, topical Efficacy/Safety
04/09/2009 Ulesfia Lotion, 5% benzyl alcohol Treatment of head lice Pediculocide, topical Efficacy/Safety
04/09/2009 Ulesfia Lotion, 5% benzyl alcohol Treatment of head lice Pediculocide, topical Efficacy/Safety
03/19/2009 Lexapro escitalopram oxalate Major depressive disorder in adolescents Antidepressant Efficacy/Safety
03/19/2009 Lexapro escitalopram oxalate Major depressive disorder in adolescents Antidepressant Efficacy/Safety
03/19/2009 Lexapro escitalopram oxalate Major depressive disorder in adolescents Antidepressant Efficacy/Safety
03/19/2009 Lexapro escitalopram oxalate Major depressive disorder in adolescents Antidepressant Efficacy/Safety
03/19/2009 Lexapro escitalopram oxalate Major depressive disorder in adolescents Antidepressant Efficacy/Safety
12/19/2008 Casodex bicalutamide Gonadotropin-independent precocious puberty in boys with familial male-limited precocious puberty (testotoxicosis) Androgen blocker Efficacy
12/18/2008 Prezista darunavir Treatment of HIV infection in pediatric patients 6 years and older when co-administered with ritonavir (Prezista/rtv), and with other antiretroviral agents Antiviral Safety/Pharmacokinetic
12/17/2008 Epiduo adapalene and benzoyl peroxide Topical treatment of acne vulgaris in patients 12 years of age and older Antiacne, topical Efficacy/Safety
12/17/2008 Epiduo adapalene and benzoyl peroxide Topical treatment of acne vulgaris in patients 12 years of age and older Antiacne, topical Efficacy/Safety
12/17/2008 Epiduo adapalene and benzoyl peroxide Topical treatment of acne vulgaris in patients 12 years of age and older Antiacne, topical Efficacy/Safety/Tolerability
12/17/2008 Epiduo adapalene and benzoyl peroxide Topical treatment of acne vulgaris in patients 12 years of age and older Antiacne, 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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