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.

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) - Get Report

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) - Get Report

Drug/indication: fingolomid for multiple sclerosis

Filing for FDA approval: December 2009

Novo Nordisk

( SHPGY)

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) - Get Report

Drug/indication: Qnexa for obesity

Filing for FDA approval: December 2009

Mannkind

(MNKD) - Get Report

Drug/indication: Afresa for diabetes

FDA approval decision date: Jan. 16, 2010

Acorda Therapeutics

(ACOR) - Get Report

Drug/indication: Amaya for multiple sclerosis

FDA approval decision date: Jan. 22, 2010

Spectrum Pharmaceuticals

(SPPI) - Get Report

Drug/indication: Fusilev for colon cancer

Outcome of meeting with FDA to discuss complete response letter: January 2010

Labopharm

( DDSS)

Drug/indication: Trazodone Contramid for depression

FDA approval decision date: Feb. 11, 2010

Cadence Pharmaceuticals

(CADX)

Drug/indication: acetavance for pain

FDA approval decision date: Feb. 12, 2010

Gilead Sciences

(GILD) - Get Report

Drug/indication: Cayston for cystic fibrosis

FDA approval decision date: Feb. 13, 2010

Salix Pharmaceuticals

(SLXP)

Drug/indication: Xifaxan for hepatic encephalopathy

FDA advisory committee meeting: February 2010

FDA approval decision date: March 24, 2010

Shire Pharmaceuticals

( SHPGY)

Drug/indication: velaglucerase for Gaucher's disease

FDA approval decision date: Feb. 28, 2010

Amylin Pharmaceuticals

( AMLN)

Drug/indication: Exenatide LAR for diabetes

FDA approval decision date: March 5, 2010

Clinical Data

( CLDA)

Drug/indication: vilazodone for depression

Filing for FDA approval: First quarter 2010

Somaxon Pharmaceuticals

( SOMX)

Drug/indication: Silenor for insomnia

Outcome of FDA meeting to discuss complete response letter: First quarter 2010

Cell Therapeutics

(CTIC) - Get Report

Drug/indication: pixantrone for non-Hodgkin's lymphoma

FDA approval decision date: April 23, 2010

Eli Lilly

(LLY) - Get Report

Drug/indication: Erbitux for first-line non-small cell lung cancer

Filing for FDA approval: First quarter 2010

Dendreon

(DNDN)

Drug/indication: Provenge for prostate cancer

FDA approval decision date: May 1, 2010

Avanir Pharmaceuticals

(AVNR)

Drug/indication: Zenvia for pseudobulbar effect

Filing for FDA approval: Second quarter 2010

Alkermes

(ALKS) - Get Report

Drug/indication: Vivitrol for opioid addiction

Filing for FDA approval: First half 2010

InterMune

(ITMN)

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)

Drug/indication: Benlysta for lupus

Filing for FDA approval: First half 2010

Orexigen Therapeutics

(OREX)

Drug/indication: Contrave for obesity

Filing for FDA approval: First half 2010

-- Reported by Adam Feuerstein in Boston

Adam Feuerstein writes regularly for TheStreet.com. In keeping with TSC's editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet.com. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback;

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