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27 Hot Drugs Facing FDA Approval in 2012

Vertex Pharmaceuticals (VRTX)
Drug/indication: Kalydeco for cystic fibrosis
Approval decision date: April 18, 2012
Kalydeco is the first drug to treat the underlying cause of cystic fibrosis in patients with a specific genetic defect.

Cell Therapeutics (CTIC)
Drug/indication: pixantrone for non-Hodgkin's lymphoma
Approval decision date: April 24, 2012
Cell Therapeutics appealed the FDA's 2009 decision to reject pixantrone, setting up the drug's second chance at U.S. approval.

Amgen (AMGN)
Drug/indication: Xgeva for prevention of bone metastases from prostate cancer.
Approval decision date: April 26, 2012

VVUS (VVUS - Get Report)
Drug/indication: Avanafil for erectile dysfunction.
Approval decision date: April 29, 2012

Pfizer (PFE) and Protalix Biotherapeutics (PLX)
Drug/indication: Uplyso for Gaucher's disease.
Approval decision date: May 1, 2012
FDA has twice-rejected Uplyso due to manufacturing and quality control issues and delayed a third decision from February to May. If approved this time around, Uplyso will compete against Sanofi/Genzyme's (SNY) Cerezyme and Shire's Vpriv.

Talon Therapeutics (TLON)
Drug/indication: Marquibo for acute lymphoblastic leukemia (ALL)
Approval decision date: May 13, 2012

Merck (MRK) and Ariad Pharmaceuticals (ARIA)
Drug/indication: ridaforolimus for sarcoma.
Approval decision date: June 5, 2012

Ironwood Pharmaceuticals (IRWD)
Drug/indication: linaclotide for irritable bowel syndrome.
Approval decision date: June 8, 2012

Navidea Biopharmaceuticals (NAVB) [Formerly <b>Neoprobe</b>]
Drug/indication: Lymphoseek, a lymph node tracing agent.
Approval decision date: June 10, 2012

Amarin (AMRN)
Drug/indication: AMR101 for dyslipidemia.
Approval decision date: July 26, 2012

Horizant Pharmaceuticals (HZNT)
Drug/indication: Lodotra for rheumatoid arthritis
Approval decision date: July 26, 2012

Onyx Pharmaceuticals (ONXX)
Drug/indication: carfilzomib for multiple myeloma
Approval decision date: July 27, 2012

Sources: Company reports, TheStreet research,

--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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