Biotech Calendar: Upcoming FDA Dates

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.

These can be make-or-break events for drug and biotech companies, so naturally, FDA decisions often move stocks significantly.

Updated FDA Calendar Click Here for the Latest Calendar

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)
Drug/indication: Droxidopa for neurogenic orthostatic hypotension
Outcome of FDA meeting to discuss changing primary endpoint of phase III study: December 2009.

Cephalon(CEPH)
Drug/indication: Nuvigil for jet lag disorder
FDA approval decision date: Dec. 29

Arena Pharmaceuticals(ARNA)
Drug/indication: lorcaserin for obesity
Filing for FDA approval: December 2009

Auxilium Pharmaceuticals(AUXL)
Drug/indication: Xiaflex for Dupuytren's contracture
FDA approval decision date: December 2009

Biodel(BIOD)
Drug/indication: Viaject for diabetes
Filing for FDA approval: December 2009

Novartis(NVS)
Drug/indication: fingolomid for multiple sclerosis
Filing for FDA approval: December 2009

Novo Nordisk(NVO)
Drug/indication: Victoza for diabetes
FDA approval decision date: December 2009

Shire Pharmaceuticals(SHPGY)
Drug/indication: Replagal for Fabry's disease
Filing for FDA approval: December 2009

Vivus(VVUS)
Drug/indication: Qnexa for obesity
Filing for FDA approval: December 2009

Mannkind(MNKD)
Drug/indication: Afresa for diabetes
FDA approval decision date: Jan. 16, 2010

Acorda Therapeutics(ACOR)
Drug/indication: Amaya for multiple sclerosis
FDA approval decision date: Jan. 22, 2010

Spectrum Pharmaceuticals(SPPI)
Drug/indication: Fusilev for colon cancer
Outcome of meeting with FDA to discuss complete response letter: January 2010