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31 Drugs Facing FDA Approval in 2012-2013

Medivation (MDVN) and Astellas
Drug/indication: Enzalutamide (MDV3100) for prostate cancer
Approval decision date: Nov. 22

GlaxoSmithKline (GSK) and Ligand Pharmaceuticals (LGND)
Drug/indication: Promacta for thrombocytopenia in hepatitis C patients
Approval decision date: Nov. 30

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.

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.

NPS Pharmaceuticals (NPSP)
Drug/indication: Gattex for short bowel syndrome
Approval decision date: Dec. 30

Drug/indication: Uceris for ulcerative colitis
Approval decision date: Jan. 16, 2013

NuPathe (PATH)
Drug/indication: Zelrix for migraine
Approval decision date: Jan. 17, 2013
This is NuPathe's second attempt at Zelrix approval.

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

Hemispherx Biopharma (HEB - Get Report)
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. 10, 2013

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

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

Sanofi (SNY)
Drug/indication: Lemtrada for multiple sclerosis
Approval decision date: April 12, 2013

Johnson & Johnson (JNJ)
Drug/indication: Zytiga for prostate cancer
Approval decision date: April 15, 2013
J&J is seeking an expanded label for Zytiga to treat "pre-chemo" prostate cancer patients.

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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