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31 Drugs Facing FDA Approval in 2012-2013

BOSTON ( TheStreet) -- Here's an updated list of biotech and pharmaceutical companies with pending FDA drug approval decisions for the rest of 2012 and into early 2013. This refresh includes changes and additions to the FDA calendar last published at the end of July.

The calendar on the following pages captures the most important U.S. regulatory events -- FDA drug approvals and advisory panels -- expected between August and March 2013. As every savvy biotech investor and trader knows, the volatility in biotech and drug stocks ramps significantly as U.S. regulators weigh whether to approve or reject new drugs.

Biotech and drug stocks below are listed in chronological order based on the closest regulatory catalyst.

Gilead Sciences (GILD)
Drug/indication: Quad for HIV
Approval decision date: Aug. 27
Quad combines four Gilead drugs into a single, once-daily pill for HIV. The new (and still experimental) components in the Quad are the integrase inhibitor elvitegravir and cobicistat, which is used to boost blood levels of elvitegravir.

Pfizer (PFE)
Drug/indication: Tofacitinib for rheumatoid arthritis
Approval decision date: August (exact date not specified)
Tofacitinib would be the first pill approved for the treatment of rheumatoid arthritis, competing with established injectable drugs like Abbbot's Humira.

Ironwood Pharmaceuticals (IRWD - Get Report)
Drug/indication: Linaclotide for chronic idiopathic constipation and irritable bowel syndrome
Approval decision date: Sept. 7

Navidea Biopharmaceuticals (NAVB - Get Report)
Drug/indication: Lymphoseek, a radioactive tracing agent for lymph node mapping
Approval decision date: Sept. 10

Sanofi (SNY)
Drug/indication: Aubagio for multiple sclerosis
Approval decision date: Sept. 12

Cornerstone Therapeutics (CRTX)
Drug/indication: Lixivaptan for hyponatremia
FDA advisory panel: Sept. 13
Approval decision date: Oct. 29

Regeneron Pharmaceuticals (REGN)
Drug/indication: Eylea for Retinal Vein Occlusion (RVO)
Approval decision date: Sept. 21
This is an additional indication for currently approved Eylea.

Bristol-Myers Squibb (BMY)
Drug/indication: Metreleptin for lipodystrophy
Approval decision date: Oct. 3

Celgene
Drug/indication: Abraxane for non-small cell lung cancer
Approval decision date: Oct. 12
Abraxane is already approved for the treatment of breast cancer.

Bayer and Onyx Pharmaceuticals (ONXX)
Drug/indication: Regorafenib for metastatic colon cancer
Approval decision date: Oct. 15-30 (No specific date disclosed)

Santarus (SNTS)
Drug/indication: Uceris for ulcerative colitis
Approval decision date: Oct. 16

Aegerion Pharmaceuticals (AEGR)
Drug/indication: Lomitapide for dyslipidemia/hypercholesterolemia
FDA advisory panel: Oct. 17
Approval decision date: Dec. 28

Sanofi and Isis Pharmaceuticals (ISIS)
Drug/indication: Kynamro for dyslipidemia/hypercholesterolemia
FDA advisory panel: Oct. 18
Approval decision date: Jan. 29, 2013

Impax Labs (IPXL)
Drug/indication: IPX066 for Parkinson's disease
Approval decision date: Oct. 19

Hyperion Therapeutics (HPTX)
Drug/indication: Ravicti for urea cell disorders
Approval decision date: Oct. 23

United Therapeutics (UTHR)
Drug/indication: Oral Remodulin for pulmonary arterial hypertension
Approval decision date: Oct. 26

Exelixis (EXEL - Get Report)
Drug/indication: Cabozantinib for medullary thyroid cancer
FDA advisory panel: Nov. 9
Approval decision date: Nov. 29

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