U.S. FDA advisory meetings through June 3
THIS DIARY IS FILED AS THE FOOD AND DRUG ADMINISTRATION UPDATES ITS SCHEDULE. ALL TIMES EDT/GMT.
PSYCHOPHARMACOLOGIC DRUGS ADVISORY COMMITTEE
DATE: April 7-8, 0800/1200
LOCATION: Hilton, 8727 Colesville Road, Silver Spring, Md.
CONTACT: Yvette Waples, 301-827-7001
On April 7, the committee will discuss safety and efficacy issues of a new drug application from Lundbeck USA (LUN.CO) for Serdolec tablets proposed for the treatment of schizophrenia.
On April 8, the committee will discuss safety and efficacy issues of supplemental new drug applications from AstraZeneca Plc (AZN.L) for Seroquel XR for the treatment of major depressive disorder and generalized anxiety disorder. Particular safety issues for discussion on April 8, regarding the Seroquel XR applications are concerns regarding exposing a greatly expanded population to a drug with known metabolic side effects and a possible risk of tardive dyskinesia.
CIRCULATORY SYSTEM DEVICES PANEL
DATE: April 23, 0830/1230
LOCATION: Hilton, 620 Perry Parkway, Gaithersburg, Md.
CONTACT: James Swink, 240-276-4050
The committee will discuss, make recommendations and vote on a premarket approval application from privately held Atritech Inc for the Watchman Left Atrial Appendage (LAA) Closure Technology. The Watchman device, a percutaneously placed permanent implant, is intended as an alternative to warfarin therapy for patients with non-valvular atrial fibrillation. The Watchman LAA Closure Technology is designed to prevent embolization of thrombi that may form in the left atrial appendage thereby preventing the occurrence of ischemic stroke and systemic thromboembolism.
RISK COMMUNICATION ADVISORY COMMITTEE
DATE: April 30 and May 1, 0800/1200
LOCATION: Food and Drug Administration, 5630 Fishers Lane, Rockville, Md.
CONTACT: Lee Zwanziger, (301) 827-2895 Continued...
