28 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.

The calendar on the following pages captures the most important U.S. regulatory events -- FDA drug approvals and advisory panels -- expected between July and February 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.

Amarin ( AMRN)
Drug/indication: Vascepa for triglyceride reduction
Approval decision date: July 26

Horizon Pharmaceuticals ( HZNP)
Drug/indication: Lodotra for rheumatoid arthritis pain
Approval decision date: July 26

Salix Pharmaceuticals ( SLXP) and Progenics ( PGNX)
Drug/indication: Relistor SC for opioid-induced constipation
Approval decision date: July 27
This is an additional indication for currently approved Relistor.

Regeneron Pharmaceuticals ( REGN)
Drug/indication: Arcalyst for prevention of gout flares
Approval decision date: July 30
This will be the second approved indication for Arcalyst, which is currently marketed as a treatment for cryopyrin-associated periodic syndromes (CAPS).

Regeneron Pharmaceuticals ( REGN) and Sanofi ( SNY)
Drug/indication: Zaltrap for colon cancer
Approval decision date: Aug. 4
Zaltrap has posted mixed results in phase III clinical trials.

Talon Therapeutics ( TLON)
Drug/indication: Marqibo for advanced acute lymphoblastic leukemia
Approval decision date: Aug. 12
In March, an FDA advisory panel voted to recommend approval of Marqibo.

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)
Drug/indication: Linaclotide for chronic idiopathic constipation and irritable bowel syndrome
Approval decision date: Sept. 8

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

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.

NPS Pharmaceuticals ( NPSP)
Drug/indication: Gattex for short bowel syndrome
Approval decision date: Sept. 28

Sanofi ( SNY)
Drug/indication: Aubagio for multiple sclerosis
Approval decision date: Third quarter

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.

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

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

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

Cornerstone Therapeutics ( CRTX)
Drug/indication: Lixivaptan for hyponatremia
Approval decision date: Oct. 29

Medivation ( MDVN) and Astellas
Drug/indication: MDV3100 for prostate cancer
Approval decision date: Nov. 21

Exelixis ( EXEL)
Drug/indication: Cabozantinib for medullary thyroid cancer
Approval decision date: Nov. 29

Alexza Pharmaceuticals ( ALXA)
Drug/indication: Adasuve for agitation due to schizophrenia
Approval decision date: Dec. 21
This is Alexza's third attempt at Adasuve approval.

Aegerion Pharmaceuticals ( AEGR)
Drug/indication: Lomitapide for dyslipidemia/hypercholesterolemia
Approval decision date: Dec. 28

Biogen Idec ( BIIB)
Drug/indication: BG-12 for multiple sclerosis
Approval decision date: Dec. 28
BG-12 would be Biogen's first pill for multiple sclerosis.

NuPathe ( PATH)
Drug/indication: Zelrix for migraine
Approval decision date: Jan. 16, 2013
This is NuPathe's second attempt at Zelrix approval.

Sanofi and Isis Pharmaceuticals ( ISIS)
Drug/indication: Kynamro for hypercholesterolemia
Approval decision date: Jan. 29, 2013

Raptor Pharmaceutical ( RPTP)
Drug/indication: RP103 for cystinosis
Approval decision date: Jan. 30, 2013.

Celgene ( CELG)
Drug/indication: Pomalidomide for multiple myeloma
Approval decision date: Feb. 10, 2013.

Dynavax ( DVAX)
Drug/indication: Heplisav for hepatitis B prevention
Approval decision date: Feb. 24, 2013

Sources: Company reports, TheStreet research, BioMedTracker.com

--Written by Adam Feuerstein in Boston.

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Adam Feuerstein writes regularly for TheStreet. In keeping with company editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback; click here to send him an email.

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