FDA's Advisory Meetings（９月20日）
公開日時 2010/09/22 04:00
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| Recent And Upcoming FDA Advisory Meetings |
|
| Topic |
Advisory Committee |
Date |
| Lilly’s Cymbalta (duloxetine HCl) for chronic pain |
Anesthetic and Life Support Drugs |
Aug. 19 |
| Jazz Pharmaceuticals’ sodium oxybate for fibromyalgia in patients age 18 and up |
Arthritis and Drug Safety and Risk Management |
Aug. 20 |
| Forest/Cerexa’s ceftaroline fosamil for community-acquired bacterial pneumonia and complicated skin and skin structure infections |
Anti-Infective Drugs |
Sept. 7 |
| Abuse potential of the cough suppressant dextromethorphan and a DEA request for a scheduling recommendation for the drug |
Drug Safety and Risk Management |
Sept. 14 |
| Statistically significant higher incidence of major cardiovascular adverse events in the Sibutramine Cardiovascular Outcomes Trial of Abbott's obesity drug Meridia (sibutramine) |
Endocrinologic and Metabolic Drugs |
Sept. 15 |
| Arena's Lorqess (lorcaserin) as an adjunct to diet and exercise for weight management in patients with a body mass index >30 kg/m2 or >27 kg/m2 with weight-related co-morbidities |
Endocrinologic and Metabolic Drugs |
Sept. 16 |
| Alkermes' Vivitrol (naltrexone for extended-release injectable suspension) for opioid dependence |
Psychopharmacologic Drugs |
Sept. 16 |
| Boehringer Ingelheim's Pradaxa (dabigatran etexilate mesylate) for stroke prevention in atrial fibrillation patients |
Cardiovascular and Renal Drugs |
Sept. 20 |
| Safety concerns with intravenous administration of the anti-seizure drugs phenytoin and fosphenytoin, including Purple Glove Syndrome, and possible regulatory actions |
Peripheral and Central Nervous System Drugs and Drug Safety and Risk Management |
Nov. 3 |
| FDA's Strategic Plan for Risk Communication and the Transparency Initiative |
Risk Communication |
Nov. 8-9 |
| Human Genome Sciences' Benlysta (belimumab) for reducing disease activity in adult patients with active, auto-antibody-positive systemic lupus erythematosus |
Arthritis Drugs |
Nov. 16 |
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