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Chart: Recent And Upcoming FDA Advisory Meetings

Executive Summary

Recent And Upcoming FDA Advisory Meetings



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

July 28

Pfizer's Revatio (sildenafil) for pediatric pulmonary arterial hypertension

Cardiovascular and Renal Drugs

July 29

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

Psychpharmacologic Drugs

Sept. 16

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

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