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2013 FDA Drug Approval Decision Calendar


BOSTON ( TheStreet) -- Here's an updated list of biotech and pharmaceutical companies with FDA drug approval decisions expected in 2013.

Biotech and drug stocks below are listed in chronological order based on the closest regulatory catalyst -- FDA drug approval decisions and advisory panels.

Johnson & Johnson (JNJ)
Drug/indication: Canagliflozin for diabetes.
FDA advisory panel: Jan. 10
Approval decision date: March 29

Theravance (THRX)
Drug/indication: Vibativ for hospital acquired pneumonia
Approval decision date: Jan. 11

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

NuPathe (PATH)
Drug/indication: Zelrix for migraine
Approval decision date: Jan. 17, 2013

Impax Labs (IPXL)
Drug/indication: IPX066 for Parkinson's disease
Approval decision date: Jan. 21

Hyperion Therapeutics (HPTX)
Drug/indication: Ravicti for urea cycle disorder
Approval decision date: Jan. 23

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

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

Hemispherx Biopharma (HEB)
Drug/indication: Ampligen for chronic fatigue syndrome
Approval decision date: Feb. 1, 2013

Celgene (CELG)
Drug/indication: Pomalidomide for multiple myeloma
Approval decision date: Feb. 8, 2013

Dynavax (DVAX)
Drug/indication: Heplisav for hepatitis B prevention
Approval decision date: Feb. 22, 2013

Roche (RHHBY) and Immunogen (IMGN)
Drug/indication: T-DM1 for breast cancer
Approval decision date Feb. 26

Zogenix (ZGNX)
Drug/indication: Zohydro for chronic pain
Approval decision date: March 1, 2013

Depomed (DEPO)
Drug/indication: Serada for menopause
FDA advisory panel: March 4
Approval decision date: May 31

Bristol-Myers Squibb (BMY)
Drug/indication: Eliquis for blood clot prevention
Approval decision date: March 15

A.P. Pharma (APPA)
Drug/indication: APF530 for chemotherapy induced nausea
Approval decision date: March 27

Biogen Idec (BIIB)
Drug/indication: BG-12 for multiple sclerosis
Approval decision date: March 28

MAP Pharma (MAPP)
Drug/indication: Levadex for migraine
Approval decision date: April 15

Sucampo Pharmaceuticals (SCMP)
Drug/indication: Amitzia for opioid-induced constipation
Approval decision date: April 26

Navidea Biopharmaceuticals (NAVB)
Drug/indication: Lymphoseek, a radioactive tracing agent for lymph node mapping
Approval decision date: April 30

GlaxoSmithKline (GSK)
Drug/indication: Dabrefenib for melanoma
FDA advisory panel: June 3

Delcath Systems (DCTH)
Drug/indication: ChemoSat for liver metastases due to ocular melanoma
Approval decision date: June 14

AVEO Pharmaceuticals (AVEO)
Drug/indication: Tivozanib for kidney cancer
Approval decision date: July 28

Companies with drugs filed to FDA but no assigned approval decision dates:

Auxillium Pharmaceuticals (AUXL): Xiaflex for Peyronie's disease
Bayer and Algeta: Alpharadin for prostate cancer
Antares Pharma (ATRS): Otrexup for rheumatoid arthritis
GlaxoSmithKline: Dolutegravir for HIV

Sources: Company reports, TheStreet research, BioMedTracker

--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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