FDA Advisory Meetings（５月31日）
公開日時 2010/06/04 04:00
| Recent And Upcoming FDA Advisory Meetings |
| Topic |
Advisory Committee |
Date |
| 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 (lan
soprazole), 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 |
| Genentech's Avastin (bevacizumab) for first-line treatment of metastatic, HER2-negative breast cancer in women, in combination with docetaxel, capecitabine, or taxanes and anthracyclines; the committee also will consider converting the existing accelerated approval to full approval for treatment in combination with paclitaxel for patients who have not received chemotherapy for locally recurrent or metastatic HER2 negative breast cancer |
Oncologic Drugs |
20-Jul |
| 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 |
（The Pink Sheet ５月31日号より） FDAと米国製薬企業の情報満載 “The Pink Sheet”はこちらから