As promised earlier, we are providing a more detailed listing of upcoming FDA Advisory Committee Meetings.
Of particular interest, Vivus‘s QNEXA is scheduled to be reviewed on Feb 22, 2012 by the Endocrinologic and Metabolic Committee for weight management. Equally important, the FDA has scheduled another meeting of the Endocrinologic and Metabolic Committee for March 28-29, 2011. Could it be that we might hear some discussion on revised guidelines?
Jan 30-31, 2012 Pediatric Advisory Committee Meeting
- The Committee will discuss the status of the development of a number of drugs for pediatric use.
Feb 8-9, 2012 Oncologic Drugs Advisory Committee Meeting
The Committee will discuss:
- XGEVA (denosumab) by Amgen for castrate resistant prostate cancer.
- DACOGEN (decitabine) by Eisai for acute myelogenous leukemia.
- PIXUVRI (pixantrone dimaleate) by Cell Therapeutics for Non-Hodgekins Lymphoma
Feb 10, 2012 Cellular, Tissue and Gene Therapies Advisory Committee Meeting
- No products are currently on the schedule for review.
Feb 10, 2012 Neurological Devices Panel Advisory Committee Meeting
- No products are currently on the schedule for review
Feb 22, 2012 Endocrinologic and Metabolic Advisory Committee Meeting
- The committee will discus QNEXA by Vivus for weight management
Feb 23, 2012 Cardiovascular and Renal Drug Advisory Committee Meeting
- The committee will discuss NORTHERA by Chelsea Therapeutics for neurogenic orthostatic Hypotension.
Feb 27, 2012 Dermatologic and Ophthalmic Drugs Advisory Committee Meeting
March 12, 2012 Arthritis Advisory Committee Meeting
March 14, 2012 Pharmaceutical Sciences and Clinical Pharmacology Advisory Committee Meeting
March 28-29, 2012 Endocrinologic and Metabolic Advisory Committee Meeting.