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FDA's Advisory Meetings(8月30日)

公開日時 2010/09/02 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
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
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
Research updates from the Laboratory of Respiratory and Special Pathogens, the Laboratory of Hepatitis Viruses and the Laboratory of Vector Borne Virus Diseases of CBER's Office of Vaccines Research and Review Vaccines and Related Biological Products Sept. 21
 

(The Pink Sheet  8月30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

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