FDA Advisory Meetings（５月17日）
公開日時 2010/05/19 04:00
| Topic |
Advisory Committee |
Date |
| Questcor Pharmaceuticals's H.P. Acthar Gel (repository corticotropin injection) for infantile spasms |
Peripheral and Central Nervous System Drugs |
6-May |
| Review of current research and strategic planning for risk communication |
Risk Communication |
May 6-7 |
| The unexpected finding of DNA originating from porcine circovirus type 1 in Rotarix, a GlaxoSmithKline vaccine against rotavirus gastroenteritis in infants; advanced analytical detection methods for the characterization of cell substrates, viral seeds and other biological materials used in the production of viral vaccines |
Vaccines and Related Biological Products |
7-May |
| NicOx's nonsteroidal anti-inflammatory drug naproxcinod for the treatment of the signs and symptoms of osteoarthritis |
Arthritis Drugs and Drug Safety and Risk Management |
12-May |
| Theratechnologies' Egrifta (tesamorelin) for reduction of excess visceral abdominal fat in HIV-infected patients with lipodystrophy |
Endocrinologic and Metabolic Drugs |
27-May |
| MedImmune's motavizumab to prevent serious lower respiratory tract disease caused by respiratory syncytial virus in high-risk children |
Antiviral Drugs |
2-Jun |
| Novartis' Gilenia (fingolimod) to treat relapsing forms of multiple sclerosis |
Peripheral and Central Nervous System Drugs |
10-Jun |
| Laboratoire HRA Pharma's ulipristal acetate, an emergency contraceptive for women's use after unprotected intercourse or a known or suspected contraceptive failure |
Reproductive Health Drugs |
17-Jun |
| Boehringer Ingelheim's flibanserin for treatment of hypoactive sexual desire disorder in premenopausal women |
Reproductive Health Drugs |
18-Jun |
| Review of Pediatric Adverse Event Reports under BCPA for Kogenate FS, (antihemophilic factor [recombinant]), Casodex (bicalutamide), Apidra (insulin glulisine [rDNA]), NovoLog (insulin aspart [rDNA]), Arimidex (anastrozole), desmopressin acetate, Prevacid (lansoprazole), Nexium (esomeprazole magnesium), Aciphex (rabeprazole sodium), Prilosec (omeprazole), OraVerse (phentolamine mesylate) and Zemuron (rocuronium bromide), and a follow-up presentation on Suprane (desflurane) |
Pediatric |
21-Jun |
| Lux Biosciences' voclosporin for noninfectious uveitis involving the posterior or intermediate segments of the eye |
Dermatologic and Ophthalmic Drugs |
28-Jun |
| Abuse potential of the cough suppressant dextromethorphan and a Drug Enforcement Administration request for a scheduling recommendation for the drug |
Drug Safety and Risk Management |
Sept. 14 |
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