FDA's Advisory Meetings（９月13日）
公開日時 2010/09/16 04:00
| Recent And Upcoming FDA Advisory Meetings |
|
| Topic |
Advisory Committee |
Date |
| 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 Brilinta(ticagrelor) for acute coronary syndrome |
Cardiovascular and Renal Drugs |
28-Jul |
| Pfizer’s Revatio(sildenafil) for pediatric pulmonary arterial hypertension |
Cardiovascular and Renal Drugs |
29-Jul |
| Valeant Pharmaceuticals North America’s Potiga(ezogabine, formerly retigabine) for adjunctive therapy in patients with partial-onset seizures |
Peripheral and Central Nervous System Drugs |
Aug. 11 |
| Interim report on CDER’s pharmacovigilance program; JANUS, the FDA-supported data standard for comparative effectiveness research; FDA’s nanotechnology research program |
Science Board |
Aug. 16 |
| 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 |
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