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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
12/14/2012 Fluarix Quadrivalent Influenza Virus Vaccine* Include a quadrivalent influenza virus vaccine formulation (Fluarix® Quadrivalent) Vaccine Safety/Immunogenicity
05/17/2012 Pertzye pancrelipase Treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions Pancreatic enzyme Efficacy/Safety
05/17/2012 Pertzye pancrelipase Treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions Pancreatic enzyme Efficacy/Safety
05/17/2012 Pertzye pancrelipase Treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions Pancreatic enzyme Efficacy/Safety
05/17/2012 Pertzye pancrelipase Treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions Pancreatic enzyme Efficacy/Safety
05/17/2012 Pertzye pancrelipase Treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions Pancreatic enzyme Efficacy/Safety
05/17/2012 Pertzye pancrelipase Treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions Pancreatic enzyme Efficacy/Safety
05/17/2012 Pertzye pancrelipase Treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions Pancreatic enzyme Efficacy/Safety
05/17/2012 Pertzye pancrelipase Treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions Pancreatic enzyme Safety
05/01/2012 Dymista azelastine hydrochloride and fluticasone proprionate Relief of symptoms of seasonal allergic rhinitis antihistamine; anti-inflammatory Efficacy/Safety
05/01/2012 Dymista azelastine hydrochloride and fluticasone proprionate Relief of symptoms of seasonal allergic rhinitis antihistamine; anti-inflammatory Efficacy/Safety
05/01/2012 Dymista azelastine hydrochloride and fluticasone proprionate Relief of symptoms of seasonal allergic rhinitis antihistamine; anti-inflammatory Efficacy/Safety
05/01/2012 Dymista azelastine hydrochloride and fluticasone proprionate Relief of symptoms of seasonal allergic rhinitis antihistamine; anti-inflammatory Efficacy/Safety/Tolerability
05/01/2012 Dymista azelastine hydrochloride and fluticasone proprionate Relief of symptoms of seasonal allergic rhinitis antihistamine; anti-inflammatory Efficacy/Safety
03/26/2012 Singulair Oral Granules, Tablets, and Chewable Tablets montelukast Prevention of exercise-induced bronchoconstriction Antiasthmatic Efficacy/Safety/Tolerability
03/26/2012 Intelence etravirine Treatment of HIV-1 infection in combination with other antiretroviral agents Antiviral Safety/Pharmacokinetic
03/26/2012 Intelence etravirine Treatment of HIV-1 infection in combination with other antiretroviral agents Antiviral Efficacy/Safety/Tolerability
03/23/2012 QNASL beclomethasone dipropionate Treatment of nasal symptoms associated with seasonal and perennial allergic rhinitis Anti-inflammatory, topical Efficacy/Safety/Tolerability
03/23/2012 QNASL beclomethasone dipropionate Treatment of nasal symptoms associated with seasonal and perennial allergic rhinitis Anti-inflammatory, topical Efficacy/Safety/Tolerability
03/23/2012 QNASL beclomethasone dipropionate Treatment of nasal symptoms associated with seasonal and perennial allergic rhinitis Anti-inflammatory, topical Efficacy/Safety/Tolerability
03/23/2012 QNASL QNASL beclomethasone dipropionate Treatment of nasal symptoms associated with seasonal and perennial allergic rhinitis Anti-inflammatory, topical Efficacy/Safety/Tolerability
03/23/2012 QNASL beclomethasone dipropionate Treatment of nasal symptoms associated with seasonal and perennial allergic rhinitis Anti-inflammatory, topical Efficacy/Safety/Tolerability
03/01/2012 Ultresa pancrelipase Treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions Pancreatic enzyme Efficacy/Safety
02/29/2012 FluMist Quadrivalent Influenza Vaccine Live, Intranasal* Active immunization for the prevention of disease caused by influenza Vaccine Efficacy/Safety/Immunogenicity
02/09/2012 Famvir famciclovir Recurrent herpes labialis Antiviral Efficacy/Safety/Pharmacokinetic
02/07/2012 Sklice ivermectin Topical treatment of head lice infestations Pediculocide, topical Safety/Pharmacokinetic/Pharmacodynamic/Tolerability
02/07/2012 Sklice ivermectin Topical treatment of head lice infestations Pediculocide, topical Efficacy/Safety/Tolerability
02/07/2012 Sklice ivermectin Topical treatment of head lice infestations Pediculocide, topical Efficacy/Safety/Pharmacokinetic/Tolerability
02/07/2012 Sklice ivermectin Topical treatment of head lice infestations Pediculocide, topical Efficacy/Safety/Tolerability
02/07/2012 Sklice ivermectin ivermectin Topical treatment of head lice infestations Pediculocide, topical Efficacy/Safety/Tolerability
02/07/2012 Sklice ivermectin Topical treatment of head lice infestations Topical treatment of head lice infestations Pediculocide, topical Efficacy/Safety/Tolerability
01/25/2012 TISSEEL Fibrin Sealant* Hemostasis: An adjunct to hemostasis in patients undergoing surgery when control of bleeding by conventional surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. TISSEEL is effective in heparinized patients. Sealing: An adjunct to standard surgical techniques (such as suture and ligature) to prevent leakage from colonic anastomoses following the reversal of temporary colostomies Wound healing Efficacy/Safety
01/18/2012 Viread tenofovir disoproxil fumarate Treatment of HIV infection in combination with other antiretroviral agents Antiviral Efficacy/Safety
01/18/2012 Viread tenofovir disoproxil fumarate Treatment of HIV infection in combination with other antiretroviral agents Antiviral Safety/Pharmacokinetic
12/21/2011 Isentress raltegravir In combination with other antiretroviral agents for the treatment of HIV-1 infection Antiviral Efficacy/Safety/Pharmacokinetic/Tolerability
12/16/2011 Maxalt and Maxalt-MLT rizatriptan Treatment of migraine Antimigraine Safety/Pharmacokinetic/Tolerability
12/16/2011 Maxalt and Maxalt-MLT rizatriptan Treatment of migraine Antimigraine Efficacy/Safety
12/16/2011 Maxalt and Maxalt-MLT rizatriptan Treatment of migraine Antimigraine Safety
12/16/2011 Prezista darunavir Treatment of HIV-1 infection in adults and pediatric patients 3 years of age and older and weighing at least 10 kg Antiviral Safety/Pharmacokinetic/Pharmacodynamic/Tolerability
12/15/2011 Nexium esomeprazole Erosive esophagitis due to acid-mediated gastroesophageal reflux disease Antiulcerative Pharmacokinetic/Pharmacodynamic
12/14/2011 Advate Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method* Routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children (0-16 years) with hemophilia A Antihemophilic Factor Efficacy/Safety/Pharmacokinetic
11/10/2011 HEMACORD hematopoietic progenitor cells, cord blood* For use in unrelated donor hematopoietic progenitor cell transplantation procedures in conjunction with an appropriate preparative regimen for hematopoietic and immunologic reconstitution in patients with disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment Somatic Cell Study summary pending
11/10/2011 HEMACORD hematopoietic progenitor cells, cord blood* For use in unrelated donor hematopoietic progenitor cell transplantation procedures in conjunction with an appropriate preparative regimen for hematopoietic and immunologic reconstitution in patients with disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment Somatic Cell Efficacy/Safety
11/10/2011 HEMACORD hematopoietic progenitor cells, cord blood* For use in unrelated donor hematopoietic progenitor cell transplantation procedures in conjunction with an appropriate preparative regimen for hematopoietic and immunologic reconstitution in patients with disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment Somatic Cell Efficacy/Safety
11/10/2011 HEMACORD hematopoietic progenitor cells, cord blood* For use in unrelated donor hematopoietic progenitor cell transplantation procedures in conjunction with an appropriate preparative regimen for hematopoietic and immunologic reconstitution in patients with disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment Somatic Cell Efficacy/Safety
11/09/2011 Chantix varenicline Smoking cessation Smoking cessation Safety/Pharmacokinetic/Tolerability
10/18/2011 Ixempra Kit ixabepilone Advanced or refractory solid tumors Antineoplastic Safety/Pharmacokinetic
10/18/2011 Ixempra Kit ixabepilone Advanced or refractory solid tumors Antineoplastic Efficacy/Safety
10/17/2011 Reyataz atazanavir Treatment of HIV - 1 infection Antiviral Safety/Pharmacokinetic
08/22/2011 Copegus and PEGASYS ribavirin and peginterferon alfa-2a Treatment of chronic hepatitis C in patients 5 to 17 years of age Antiviral Efficacy/Safety
08/22/2011 Copegus and PEGASYS ribavirin and peginterferon alfa-2a Treatment of chronic hepatitis C in patients 5 to 17 years of age Antiviral Safety/Pharmacokinetics
07/22/2011 GAMMAGARD LIQUID Immune Globulin Infusion (Human)* Treatment of patients with primary immunodeficiency associated with defects in humoral immunity in adults and pediatric patients two years of age or older Immunomodulator Pharmacokinetic/Tolerability
07/19/2011 CERVARIX Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant* Postmarketing Study Preventive Vaccine Safety/Immunogenicity
05/17/2011 Faslodex Injection fulvestrant Use in girls with progressive precocious puberty associated with McCune-Albright Syndrome Estrogen lowering agent Efficacy/Safety
05/06/2011 Plavix clopidogrel bisulfate Reduction of the incidence of thrombosis in children with systemic to pulmonary artery shunts for palliation of cyanotic congenital heart disease Platelet inhibitor Pharmacokinetic/Pharmacodynamic
05/06/2011 Plavix clopidogrel bisulfate Reduction of the incidence of thrombosis in children with systemic to pulmonary artery shunts for palliation of cyanotic congenital heart disease Platelet inhibitor Efficacy/Safety
04/29/2011 Kytril Injection granisetron hydrochloride Prevention of postoperative nausea and vomiting Antiemetic Efficacy/Safety
04/29/2011 Nexium IV esomeprazole Treatment of Gastroesophageal Reflux Disease (GERD) with erosive esophagitis Antiulcerative Pharmacokinetic
04/25/2011 Lamictal XR lamotrigine Monotherapy in patients 13 years of age and older with partial seizures who are receiving therapy with a single antiepileptic drug (AED) Anticonvulsant Efficacy/Safety
04/25/2011 Lamictal XR lamotrigine Monotherapy in patients 13 years of age and older with partial seizures who are receiving therapy with a single antiepileptic drug (AED) Anticonvulsant Efficacy/Safety
04/22/2011 Menactra Meningococcal Polysaccharide (Serogroups A, C, Y and W-135) Diphtheria Toxoid Conjugate Vaccine)* Active immunization of individuals 9 months through 55 years of age for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135 Preventive Vaccine Safety/Immunogenicity
04/22/2011 Menactra Meningococcal Polysaccharide (Serogroups A, C, Y and W-135) Diphtheria Toxoid Conjugate Vaccine)* Active immunization of individuals 9 months through 55 years of age for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135 Preventive Vaccine Safety/Immunogenicity
04/22/2011 Menactra Meningococcal Polysaccharide (Serogroups A, C, Y and W-135) Diphtheria Toxoid Conjugate Vaccine)* Active immunization of individuals 9 months through 55 years of age for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135 Preventive Vaccine Safety
04/15/2011 Actemra tocilizumab Treatment of active Systemic Juvenile Idiopathic Arthritis (SJIA) Biological response modifier Efficacy/Safety
04/15/2011 Actemra tocilizumab Treatment of active Systemic Juvenile Idiopathic Arthritis (SJIA) Biological response modifier Safety/Pharmacokinetic
04/15/2011 Actemra tocilizumab Treatment of active Systemic Juvenile Idiopathic Arthritis (SJIA) Biological response modifier Efficacy/Safety/Pharmacokinetic
04/15/2011 Actemra tocilizumab Treatment of active Systemic Juvenile Idiopathic Arthritis (SJIA) Biological response modifier Efficacy/Safety/Pharmacokinetic
04/15/2011 Actemra tocilizumab Treatment of active Systemic Juvenile Idiopathic Arthritis (SJIA) Biological response modifier Efficacy
04/06/2011 Invega paliperidone Treatment of schizophrenia Antipsychotic Safety
04/06/2011 Invega paliperidone Treatment of schizophrenia Antipsychotic Efficacy/Safety/Tolerability
04/06/2011 Invega paliperidone Treatment of schizophrenia Antipsychotic Safety/Pharmacokinetics
03/17/2011 Alimta pemetrexed disodium Refractory and recurrent solid tumors, including osteosarcoma, Ewing sarcoma/peripheral PNET, rhabdomyosarcoma, and neuroblastoma Antineoplastic Pharmacokinetic
03/17/2011 Alimta pemetrexed disodium Refractory and recurrent solid tumors, including osteosarcoma, Ewing sarcoma/peripheral PNET, rhabdomyosarcoma, and neuroblastoma Antineoplastic Efficacy/Safety
03/14/2011 Gadavist gadobutrol Detect and visualize areas with disrupted blood brain barrier (BBB) and/or abnormal vascularity of the central nervous system Medical imaging Safety/Pharmacokinetic/Tolerability
02/25/2011 Intuniv guanfacine Adjunctive treatment with long-acting oral psychostimulants for the treatment of ADHD Non-stimulant ADHD treatment Efficacy/Safety
02/17/2011 Hizentra Globulin Subcutaneous (Human), 20% Liquid * Postmarketing study Immune Serum Efficacy/Safety/Pharmacokinetic/Tolerability
01/28/2011 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
01/18/2011 Natroba spinosad Treatment of head lice infestation in patients 4 years of age and older Pediculocide, topical Pharmacokinetic/Tolerability
01/18/2011 Natroba spinosad Treatment of head lice infestation in patients 4 years of age and older Pediculocide, topical Pharmacokinetic/Tolerability
01/18/2011 Natroba spinosad Treatment of head lice infestation in patients 4 years of age and older Pediculocide, topical Efficacy/Safety
12/22/2010 GARDASIL Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant* Prevention of anal cancer caused by HPV types 16 and 18, and prevention of anal intraepithelial neoplasia (AIN) grades 1, 2, and 3 caused by HPV types included in the vaccine Preventive Vaccine Efficacy/Safety/Immunogenicity
12/21/2010 INOmax nitric oxide Prevention of bronchopulmonary dysplasia Pulmonary vasodilator Efficacy/Safety
12/21/2010 INOmax nitric oxide Prevention of bronchopulmonary dysplasia Pulmonary vasodilator Efficacy/Safety
12/21/2010 INOmax nitric oxide Prevention of bronchopulmonary dysplasia Pulmonary vasodilator Efficacy/Safety
12/15/2010 Uroxatral alfuzosin Elevated detrusor leak point pressure of neurologic origin Urology Pharmacokinetic
12/15/2010 Uroxatral alfuzosin Elevated detrusor leak point pressure of neurologic origin Urology Efficacy/Safety
12/15/2010 Uroxatral alfuzosin Elevated detrusor leak point pressure of neurologic origin Urology Efficacy/Safety
11/19/2010 Moxeza Ophthalmic Solution moxifloxacin Bacterial conjunctivitis Antibiotic Efficacy/Safety
11/19/2010 Moxeza Ophthalmic Solution moxifloxacin Bacterial conjunctivitis Antibiotic Efficacy/Safety
11/10/2010 Vyvanse Capsules lisdexamfetamine ADHD CNS Stimulant Efficacy/Safety
11/10/2010 Vyvanse Capsules lisdexamfetamine ADHD CNS Stimulant Efficacy/Safety
11/02/2010 Ofirmev acetaminophen Management of mild-to-moderate pain, for the management of moderate-to-severe pain with adjunctive opioid analgesics, and for the reduction of fever Analgesic; Antipyretic Efficacy/Safety/Tolerability
11/02/2010 Ofirmev acetaminophen Management of mild-to-moderate pain, for the management of moderate-to-severe pain with adjunctive opioid analgesics, and for the reduction of fever Analgesic; Antipyretic Safety/Pharmacokinetic
11/02/2010 Ofirmev acetaminophen Management of mild-to-moderate pain, for the management of moderate-to-severe pain with adjunctive opioid analgesics, and for the reduction of fever Analgesic; Antipyretic Safety
11/02/2010 Ofirmev acetaminophen Management of mild-to-moderate pain, for the management of moderate-to-severe pain with adjunctive opioid analgesics, and for the reduction of fever Analgesic; Antipyretic Efficacy
10/29/2010 Afinitor everolimus Treatment of patients with subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis Antineoplastic Efficacy/Safety
10/05/2010 Aridol Powder for Inhalation mannitol Assessment of bronchial hyperresponsiveness in patients without clinically apparent asthma Diagnostic aid Efficacy/Safety
10/05/2010 Aridol Powder for Inhalation mannitol Assessment of bronchial hyperresponsiveness in patients without clinically apparent asthma Diagnostic aid Efficacy/Safety
10/05/2010 Aridol Powder for Inhalation mannitol Assessment of bronchial hyperresponsiveness in patients without clinically apparent asthma Diagnostic aid Pharmacokinetic/Pharmacodynamic
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 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 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
06/29/2010 Daytrana methylphenidate ADHD CNS Stimulant Efficacy/Safety
06/29/2010 Daytrana methylphenidate ADHD CNS Stimulant Pharmacokinetic
06/29/2010 Daytrana methylphenidate ADHD CNS Stimulant 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
06/22/2010 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 Differin Lotion adapalene Acne Antiacne, topical Efficacy/Safety
03/17/2010 MultiHance Injection gadobenate dimeglumine Intravenous use in magnetic resonance imaging Diagnostic aid Efficacy/Safety
03/17/2010 MultiHance Injection gadobenate dimeglumine Intravenous use in magnetic resonance imaging Diagnostic aid Safety/Pharmacokinetic
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
02/24/2010 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
02/22/2010 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 Efficacy/Safety/Pharmacokinetic
02/04/2010 Benicar olmesartan Hypertension Antihypertensive 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 Efficacy/Safety/Pharmacokinetic/Pharmacodynamic
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
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
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
12/22/2009 Flomax tamsulosin Treatment of elevated detrusor leak point pressure associated with neurological disorder Urology Efficacy/Safety/Pharmacokinetic
12/22/2009 Flomax tamsulosin Treatment of elevated detrusor leak point pressure associated with neurological disorder Urology Safety/Pharmacokinetic/Pharmacodynamic
12/22/2009 Topamax topiramate Adjunctive Treatment for Partial Onset Epilepsy in Infants and Toddlers 1 to 24 months Anticonvulsant Efficacy/Safety
12/22/2009 Topamax topiramate Adjunctive Treatment for Partial Onset Epilepsy in Infants and Toddlers 1 to 24 months Anticonvulsant Pharmacokinetic/Tolerability
12/22/2009 Topamax topiramate Adjunctive Treatment for Partial Onset Epilepsy in Infants and Toddlers 1 to 24 months Anticonvulsant Safety/Pharmacokinetic/Tolerability
12/14/2009 Daytrana methylphenidate Postmarketing safety study CNS Stimulant Safety
12/02/2009 Seroquel quetiapine Treatment of schizophrenia in adolescents 13 to 17 years of age and the treatment of bipolar mania in children and adolescents 10 to 17 years of age Antipsychotic Safety/Pharmacokinetic/Tolerability
12/02/2009 Seroquel quetiapine Treatment of schizophrenia in adolescents 13 to 17 years of age and the treatment of bipolar mania in children and adolescents 10 to 17 years of age Antipsychotic Efficacy/Safety
12/02/2009 Seroquel quetiapine Treatment of schizophrenia in adolescents 13 to 17 years of age and the treatment of bipolar mania in children and adolescents 10 to 17 years of age Antipsychotic Efficacy/Safety
12/02/2009 Seroquel quetiapine Treatment of schizophrenia in adolescents 13 to 17 years of age and the treatment of bipolar mania in children and adolescents 10 to 17 years of age Antipsychotic Safety/Tolerability
12/01/2009 Patanase olopatadine Seasonal allergic rhinitis Antihistamine Efficacy/Safety 6 to <12 years
12/01/2009 Patanase olopatadine Seasonal allergic rhinitis Antihistamine Safety/Pharmacokinetic in 2 to <6 years
11/19/2009 Abilify aripiprazole Irritability associated with autistic disorder Antipsychotic Efficacy/Safety/Tolerability
11/19/2009 Abilify aripiprazole Irritability associated with autistic disorder Antipsychotic Efficacy/Safety/Tolerability
11/12/2009 Protonix pantoprazole GERD Antiulcerative Safety/Pharmacokinetic/Pharmacodynamic
11/12/2009 Protonix pantoprazole GERD Antiulcerative Efficacy/Safety/Pharmacokinetic
11/12/2009 Protonix pantoprazole GERD Antiulcerative Efficacy/Safety
11/12/2009 Protonix pantoprazole GERD Antiulcerative Safety/Pharmacokinetic/Pharmacodynamic
11/12/2009 Protonix pantoprazole GERD Antiulcerative Safety/Pharmacokinetic
11/10/2009 AFLURIA Influenza Virus Vaccine* Active immunization for the prevention of influenza disease caused by virus types A and B contained in the vaccine Preventive Vaccine Safety/Immunogenicity
10/23/2009 Focalin XR dexmethylphenidate ADHD CNS Stimulant Efficacy/Safety/Tolerability
10/22/2009 Atacand candesartan Hypertension Antihypertensive Efficacy/Safety/Pharmacokinetic
10/22/2009 Atacand candesartan Hypertension Antihypertensive Efficacy/Safety/Pharmacokinetic
10/22/2009 Atacand candesartan Hypertension Antihypertensive Efficacy/Safety/Pharmacokinetic
10/19/2009 Fluarix Influenza Virus Vaccine* Active immunization for the prevention of influenza disease caused by virus types A and B contained in the vaccine Preventive Vaccine Safety/Immunogenicity
10/16/2009 CERVARIX Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant* Prevention of genital warts caused by HPV 16 and 18 Preventive Vaccine Safety/Immunogenicity
10/16/2009 CERVARIX Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant* Prevention of genital warts caused by HPV 16 and 18 Preventive Vaccine Safety/Immunogenicity
10/16/2009 CERVARIX Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant* Prevention of genital warts caused by HPV 16 and 18 Preventive Vaccine Efficacy/Safety/Immunogenicity
10/16/2009 CERVARIX Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant* Prevention of genital warts caused by HPV 16 and 18 Preventive Vaccine Efficacy/Safety/Immunogenicity
10/16/2009 GARDASIL Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant* Prevention of genital warts caused by HPV 6 and 11 Preventive Vaccine Safety/Immunogenicity
10/15/2009 Crestor rosuvastatin Heterozygous familial hypercholesterolemia Antilipemic Efficacy/Safety
10/02/2009 Welchol colesevelam Heterozygous familial hypercholesterolemia Antilipemic Efficacy/Safety
09/08/2009 Bepreve Ophthalmic Solution bepotastine besilate Ocular itching associated with allergic conjunctivitis Antihistamine, topical Safety
09/02/2009 Intuniv guanfacine ADHD Non-stimulant ADHD treatment Efficacy/Safety
09/02/2009 Intuniv guanfacine ADHD Non-stimulant ADHD treatment Pharmacokinetic
09/02/2009 Intuniv guanfacine ADHD Non-stimulant ADHD treatment Safety/Pharmacokinetic/Tolerability
09/02/2009 Intuniv guanfacine ADHD Non-stimulant ADHD treatment Efficacy/Safety/Pharmacokinetic/Pharmacodynamic/Tolerability
09/02/2009 Intuniv guanfacine ADHD Non-stimulant ADHD treatment Safety/Tolerability
09/02/2009 Intuniv guanfacine ADHD Non-stimulant ADHD treatment Efficacy/Safety/Tolerability
09/02/2009 Intuniv guanfacine ADHD Non-stimulant ADHD treatment Efficacy/Safety
09/02/2009 Intuniv guanfacine ADHD Non-stimulant ADHD treatment Efficacy/Safety/Tolerability
09/02/2009 Intuniv guanfacine ADHD Non-stimulant ADHD treatment Efficacy/Safety/Tolerability
09/02/2009 Intuniv guanfacine ADHD Non-stimulant ADHD treatment Efficacy/Safety
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 Efficacy/Safety
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 Efficacy/Safety
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 Efficacy/Safety
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
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
12/11/2008 PegIntron Peginterferon alfa-2b Co-administered with ritonavir to treat chronic hepatitis C in patients 3 years of age and older with compensated liver disease previously untreated with interferon alpha Antiviral Efficacy/Safety/Pharmacokinetic/Tolerability
12/05/2008 Arimidex anastrozole Male pubertal patients with gynecomastia and female pediatric patients with McCune-Albright syndrome with progressive precocious puberty Estrogen lowering agent Pharmacokinetic/Pharmacodynamic
12/05/2008 Arimidex anastrozole Male pubertal patients with gynecomastia and female pediatric patients with McCune-Albright syndrome with progressive precocious puberty Estrogen lowering agent Efficacy/Safety
12/05/2008 Arimidex anastrozole Male pubertal patients with gynecomastia and female pediatric patients with McCune-Albright syndrome with progressive precocious puberty Estrogen lowering agent Efficacy/Safety
12/05/2008 Arimidex anastrozole Male pubertal patients with gynecomastia and female pediatric patients with McCune-Albright syndrome with progressive precocious puberty Estrogen lowering agent Pharmacokinetic
11/14/2008 Neulasta Pefilgrastim Decrease the incidence of infection in pediatric patients with sarcoma Hematopoietic Safety/Pharmacokinetic
10/28/2008 Prevacid lansoprazole Symptomatic GERD in infants Antiulcerative Efficacy/Safety/Pharmacokinetic
10/24/2008 Apidra insulin glulisine recombinant Diabetes Mellitus Antidiabetic Efficacy/Safety
10/24/2008 Apidra insulin glulisine recombinant Diabetes Mellitus Antidiabetic Safety/Pharmacokinetic/Pharmacodynamic
10/21/2008 Acanya Gel clindamycin/ benzoyl peroxide combination Acne vulgaris in patients 12 years of age and older Antiacne, topical Other
10/21/2008 Acanya Gel clindamycin/ benzoyl peroxide combination Acne vulgaris in patients 12 years of age and older Antiacne, topical Efficacy/Safety
10/21/2008 Acanya Gel clindamycin/ benzoyl peroxide combination Acne vulgaris in patients 12 years of age and older Antiacne, topical Efficacy/Safety
10/21/2008 Acanya Gel clindamycin/ benzoyl peroxide combination Acne vulgaris in patients 12 years of age and older Antiacne, topical Efficacy/Safety
10/10/2008 Kogenate FS Antihemophilic Factor (Recombinant)* Routine prophylaxis to reduce the frequency of bleeding episodes and the risk of joint damage in children with hemophilia A with no pre-existing joint damage Hematology/Coagulation Efficacy/Safety
09/19/2008 Nasacort AQ triamcinolone Treatment of the nasal symptoms of seasonal and perennial allergic rhinitis in adults and children 2 years of age and older Anti-inflammatory, topical Safety
09/19/2008 Nasacort AQ triamcinolone Treatment of the nasal symptoms of seasonal and perennial allergic rhinitis in adults and children 2 years of age and older Anti-inflammatory, topical Safety/Pharmacokinetic
09/19/2008 Nasacort AQ triamcinolone Treatment of the nasal symptoms of seasonal and perennial allergic rhinitis in adults and children 2 years of age and older Anti-inflammatory, topical Efficacy/Safety
09/12/2008 GARDASIL Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant* Prevention of vulvar and vaginal cancer caused by HPV types 16 and 18 Preventive Vaccine Efficacy/Safety/Immunogenicity
09/03/2008 Valtrex valacyclovir Chickenpox; active or at risk for herpes virus infection Antiviral Safety/Pharmacokinetic/Tolerability
09/03/2008 Valtrex valacyclovir Chickenpox; active or at risk for herpes virus infection Antiviral Safety/Pharmacokinetic/Tolerability
09/03/2008 Valtrex valacyclovir Chickenpox; active or at risk for herpes virus infection Antiviral Safety/Pharmacokinetic/Tolerability
08/28/2008 Zemuron rocuronium Adjunct to general anesthesia Anesthetic agent Efficacy/Safety
08/28/2008 Zemuron rocuronium Adjunct to general anesthesia Anesthetic agent Safety/Pharmacokinetic/Pharmacodynamic
08/14/2008 Zyprexa olanzapine schizophrenia; bipolar disorder Antipsychotic Efficacy/Safety
08/14/2008 Zyprexa olanzapine schizophrenia; bipolar disorder Antipsychotic Pharmacokinetic
08/14/2008 Zyprexa olanzapine schizophrenia; bipolar disorder Antipsychotic Safety/Pharmacokinetic
08/14/2008 Zyprexa olanzapine schizophrenia; bipolar disorder Antipsychotic Pharmacokinetic
08/14/2008 Zyprexa olanzapine schizophrenia; bipolar disorder Antipsychotic Efficacy/Safety
08/14/2008 Zyprexa olanzapine schizophrenia; bipolar disorder Antipsychotic Efficacy/Safety
07/29/2008 Cancidas caspofungin Empirical therapy for presumed fungal infections in febrile, neutropenic patients; Candidemia and certain Candida infections; Esophageal Candidiasis; Invasive Aspergillosis in patients who are refractory to or intolerant of other therapies Antifungal Safety/Pharmacokinetic
07/29/2008 Cancidas caspofungin Empirical therapy for presumed fungal infections in febrile, neutropenic patients; Candidemia and certain Candida infections; Esophageal Candidiasis; Invasive Aspergillosis in patients who are refractory to or intolerant of other therapies Antifungal Safety/Pharmacokinetic/Tolerability (2/3)
07/29/2008 Cancidas caspofungin Empirical therapy for presumed fungal infections in febrile, neutropenic patients; Candidemia and certain Candida infections; Esophageal Candidiasis; Invasive Aspergillosis in patients who are refractory to or intolerant of other therapies Antifungal Safety/Pharmacokinetic/Tolerability (3/3)
07/29/2008 Cancidas caspofungin Empirical therapy for presumed fungal infections in febrile, neutropenic patients; Candidemia and certain Candida infections; Esophageal Candidiasis; Invasive Aspergillosis in patients who are refractory to or intolerant of other therapies Antifungal Efficacy/Safety/Tolerability
07/29/2008 Cancidas caspofungin Empirical therapy for presumed fungal infections in febrile, neutropenic patients; Candidemia and certain Candida infections; Esophageal Candidiasis; Invasive Aspergillosis in patients who are refractory to or intolerant of other therapies Antifungal Efficacy/Safety/Tolerability
07/01/2008 Flovent HFA fluticasone propionate Asthma in < 4 years Antiasthmatic Safety/Pharmacokinetic/Pharmacodynamic/Tolerability
06/30/2008 Aciphex rabeprazole Gastroesophageal reflux in adolescent patients 12 years of age and above Antiulcerative Efficacy/Safety
06/30/2008 Aciphex rabeprazole Gastroesophageal reflux in adolescent patients 12 years of age and above Antiulcerative Pharmacokinetic
06/24/2008 KINRIX Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine* Active immunization against diphtheria, tetanus, pertussis, & poliomyelitis as the fifth dose in the diphtheria, tetanus, and acellular pertussis (DTaP) vaccine series and the fourth dose in the inactivated poliovirus vaccine (IPV) series when previous DTaP vaccine doses have been with INFANRIX and/or PEDIARIX and for the first three doses and INFANRIX for the fourth dose Preventive Vaccine Safety/Immunogenicity
06/24/2008 KINRIX Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine* Active immunization against diphtheria, tetanus, pertussis, & poliomyelitis as the fifth dose in the diphtheria, tetanus, and acellular pertussis (DTaP) vaccine series and the fourth dose in the inactivated poliovirus vaccine (IPV) series when previous DTaP vaccine doses have been with INFANRIX and/or PEDIARIX and for the first three doses and INFANRIX for the fourth dose Preventive Vaccine Safety/Immunogenicity
06/24/2008 KINRIX Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine* Active immunization against diphtheria, tetanus, pertussis, & poliomyelitis as the fifth dose in the diphtheria, tetanus, and acellular pertussis (DTaP) vaccine series and the fourth dose in the inactivated poliovirus vaccine (IPV) series when previous DTaP vaccine doses have been with INFANRIX and/or PEDIARIX and for the first three doses and INFANRIX for the fourth dose Preventive Vaccine Safety/Immunogenicity
06/24/2008 Viramune Tablets 200 mg Viramune Oral Suspension 10 mg/mL nevirapine Use in combination with other antiretroviral agents for the treatment of HIV-1 infection Antiviral Safety/Pharmacokinetic/Tolerability
06/23/2008 Aptivus tipranavir Co-administered with ritonavir for combination antiretroviral in patients who are treatment-experienced and infected with HIV-1 strains resistant to more than one protease inhibitor Antiviral Safety/Pharmacokinetic/Tolerability
06/20/2008 Kaletra lopinavir/ ritonavir Use in combination with other antiretroviral agents for HIV-1 infection Antiviral Safety/Pharmacokinetic/Tolerability
06/20/2008 Kaletra lopinavir/ ritonavir Use in combination with other antiretroviral agents for HIV-1 infection Antiviral Efficacy/Safety/Pharmacokinetic/Tolerability
06/20/2008 Kaletra lopinavir/ ritonavir Use in combination with other antiretroviral agents for HIV-1 infection Antiviral Efficacy/Safety/Pharmacokinetic/Tolerability
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
06/20/2008 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
06/20/2008 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
06/20/2008 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
06/20/2008 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
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 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
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
01/31/2008 Inspra eplerenone Hypertension Antihypertensive Efficacy/Safety
01/31/2008 Inspra eplerenone Hypertension Antihypertensive Safety/Pharmacokinetic
01/31/2008 Inspra eplerenone Hypertension Antihypertensive Pharmacokinetic
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
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 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/Pharmacodynamic
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
01/02/2008 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 Safety/Pharmacokinetic
12/27/2007 AndroGel testosterone Use in adolescent boys with delayed puberty Androgen-anabolic steroid Efficacy/Safety
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 Pharmacokinetic
11/29/2007 Diovan valsartan Hypertension Antihypertensive Safety
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 Safety/Tolerability
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
10/29/2007 Abilify aripiprazole Schizophrenia Antipsychotic Efficacy/Safety
10/29/2007 Abilify aripiprazole Schizophrenia Antipsychotic Pharmacokinetic
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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