FDA's Advisory Meetings（８月２日）
公開日時 2010/08/04 04:00
| Topic |
Advisory Committee |
Date |
| Cardiovascular safety of GlaxoSmithKline's diabetes drug Avandia (rosiglitazone 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 BMI of 30 kg/m2 or 27 kg/m2 or more with co-morbidities |
Endocrinologic and Metabolic Drugs |
15-Jul |
| Genentech's Avastin (bevacizumab) for first-line treatment of metastatic, HER2-negative breast cancer in women, combined with docetaxel, capecitabine, or taxanes and anthracyclines; the panel also will consider full approval for use in combination with paclitaxel in certain patients |
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 |
| Blood safety and availability, emerging arboviruses, emerging infectious diseases, the Q fever epidemic in the Netherlands, xenotropic murine leukemia virus-related virus, babesia infections |
Blood Products |
26-Jul |
| Blood donor hemoglobin/hematocrit standards, iron status and interdonation interval |
Blood Products |
27-Jul |
| 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 |
| 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 Drug Enforcement Administration request for a scheduling recommendation for the drug |
Drug Safety and Risk Management |
Sept. 14 |
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