FDA Advisory Meetings（６月21日）
公開日時 2010/06/23 04:00
| Topic |
Advisory Committee |
Date |
| 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 |
| Cardiovascular safety of GlaxoSmithKline's diabetes drug Avandia (rosaglitazone maleate) |
Endocrinologic and Metabolic Drugs and Drug Safety and Risk Management |
July 13-14 |
| Vivus' Qnexa (phentermine/topiramate) as an adjunct to diet and exercise for weight management in patients with a body mass index of 30 kg per square meter, or 27 kg per square meter or more if accompanied by weight-related co-morbidities |
Endocrinologic and Metabolic Drugs |
15-Jul |
| 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 |
| Class-wide Risk Evaluation and Mitigation Strategy for opioid drugs |
Anesthetic and Life Support Drugs and Drug Safety and Risk Management |
July 22-23 |
| AstraZeneca's ticagrelor for acute coronary syndrome |
Cardiovascular and Renal Drugs |
28-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 |
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