FDA Advisory Committee Schedule

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.