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.
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
Labopharm(DDSS Quote)
Drug/indication: Trazodone Contramid for depression
FDA approval decision date: Feb. 11, 2010
Cadence Pharmaceuticals(CADX Quote)
Drug/indication: acetavance for pain
FDA approval decision date: Feb. 12, 2010
Gilead Sciences(GILD Quote)
Drug/indication: Cayston for cystic fibrosis
FDA approval decision date: Feb. 13, 2010
Salix Pharmaceuticals(SLXP Quote)
Drug/indication: Xifaxan for hepatic encephalopathy
FDA advisory committee meeting: February 2010
FDA approval decision date: March 24, 2010
Shire Pharmaceuticals(SHPGY Quote)
Drug/indication: velaglucerase for Gaucher’s disease
FDA approval decision date: Feb. 28, 2010
Amylin Pharmaceuticals(AMLN Quote)
Drug/indication: Exenatide LAR for diabetes
FDA approval decision date: March 5, 2010
Clinical Data(CLDA Quote)
Drug/indication: vilazodone for depression
Filing for FDA approval: First quarter 2010
Somaxon Pharmaceuticals(SOMX Quote)
Drug/indication: Silenor for insomnia
Outcome of FDA meeting to discuss complete response letter: First quarter 2010
Cell Therapeutics(CTIC Quote)
Drug/indication: pixantrone for non-Hodgkin’s lymphoma
FDA approval decision date: April 23, 2010
Eli Lilly(LLY Quote)
Drug/indication: Erbitux for first-line non-small cell lung cancer
Filing for FDA approval: First quarter 2010
Dendreon(DNDN Quote)
Drug/indication: Provenge for prostate cancer
FDA approval decision date: May 1, 2010
Avanir Pharmaceuticals(AVNR Quote)
Drug/indication: Zenvia for pseudobulbar effect
Filing for FDA approval: Second quarter 2010
Alkermes(ALKS Quote)
Drug/indication: Vivitrol for opioid addiction
Filing for FDA approval: First half 2010
InterMune(ITMN Quote)
Drug/indication: pirfenidone for idiopathic pulmonary fibrosis
FDA advisory committee meeting: First half 2010
FDA approval decision date: Second half 2010
Human Genome Sciences(HGSI Quote)
Drug/indication: Benlysta for lupus
Filing for FDA approval: First half 2010
Orexigen Therapeutics(OREX Quote)
Drug/indication: Contrave for obesity
Filing for FDA approval: First half 2010
http://www.thestreet.com/story/10645419/1/biotech-calendar-upcoming-fda-dates.html