BOSTON, Mass. (TheStreet) --To get ready for 2010, I've put together a new calendar of expected U.S. Food and Drug Administration approval decisions.
More on DNDN Market Activity Avanir Pharmaceuticals Incorporated| AVNR DOWNHuman Genome Sciences Inc.| HGSI UPCell Therapeutics Incorporated| CTIC DOWNThese can be make-or-break events for drug and biotech companies, so naturally, FDA decisions often move stocks significantly.
The following calendar covers most of the expected drug approval decisions by the FDA through the end of June 2010. I expanded the calendar to include drug application filings and other important regulatory events like advisory committee meetings.
I put the calendar together using company reports and the BioMedTracker service from Sagient Research -- a handy, subscription-based tool for keeping track of biotech and drug catalysts.
Chelsea Therapeutics(CHTP Quote)
Drug/indication: Droxidopa for neurogenic orthostatic hypotension
Outcome of FDA meeting to discuss changing primary endpoint of phase III study: December 2009.
Cephalon(CEPH Quote)
Drug/indication: Nuvigil for jet lag disorder
FDA approval decision date: Dec. 29
Arena Pharmaceuticals(ARNA Quote)
Drug/indication: lorcaserin for obesity
Filing for FDA approval: December 2009
Auxilium Pharmaceuticals(AUXL Quote)
Drug/indication: Xiaflex for Dupuytren's contracture
FDA approval decision date: December 2009
Biodel(BIOD Quote)
Drug/indication: Viaject for diabetes
Filing for FDA approval: December 2009
Novartis(NVS Quote)
Drug/indication: fingolomid for multiple sclerosis
Filing for FDA approval: December 2009
Novo Nordisk(NVO Quote)
Drug/indication: Victoza for diabetes
FDA approval decision date: December 2009
Shire Pharmaceuticals(SHPGY Quote)
Drug/indication: Replagal for Fabry's disease
Filing for FDA approval: December 2009
Vivus(VVUS Quote)
Drug/indication: Qnexa for obesity
Filing for FDA approval: December 2009
Mannkind(MNKD Quote)
Drug/indication: Afresa for diabetes
FDA approval decision date: Jan. 16, 2010
Acorda Therapeutics(ACOR Quote)
Drug/indication: Amaya for multiple sclerosis
FDA approval decision date: Jan. 22, 2010
Spectrum Pharmaceuticals(SPPI Quote)
Drug/indication: Fusilev for colon cancer
Outcome of meeting with FDA to discuss complete response letter: January 2010
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