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22 Hot Drugs Facing FDA Approval in 2012

Biogen Idec (BIIB) and Elan (ELN)
Drug/indication:Update to the Tysabri prescribing label
Approval decision date: Jan. 20, 2012
The Tysabri label update will include information about the anti-JC virus antibody status as a factor to help stratify the risk of progressive multifocal leukoencephalopathy (PML). Doctors can use to test to determine which multiple sclerosis patients are at low or high risk for PML, a serious, potentially fatal brain infection caused by Tysabri.

Columbia Labs (CBRX) and Watson Pharmaceuticals (WPI)
Drug/indication:progesterone vaginal gel for risk reduction of preterm birth.
FDA advisory panel: Jan. 20, 2012
Approval decision date:Feb. 26, 2012

Amylin Pharmaceuticals (AMLN)
Drug/indication: Bydureon for diabetes
Approval decision date: Jan. 27, 2012
This is the second shot at approval for Bydureon, a once-weekly injectable medicine for the treatment of Type 2 diabetes. Amylin recently split with its long-time marketing partner Eli Lilly (LLY). Alkermes (ALKS) retains its royalty split on Bydureon sales.

Bristol-Myers Squibb (BMY)
Drug/indication: dapagliflozin for diabetes
Approval decision date: Jan. 27, 2012

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

Teva (TEVA) and BioSante Pharmaceuticals (BPAX)
Drug/indication: Bio-T-Gel for hypogonadism
Approval decision date: Feb. 14, 2012
Bio-T-Gel is a once-daily gel used to treat low testosterone in men.

Corcept Pharmaceuticals (CORT)
Drug/indication: Corlux for Cushing's Syndrome.
Approval decision date: Feb. 17, 2012
FDA will not convene an advisory panel to review Corlux.

Discovery Labs (DSCO)
Drug/indication: Surfaxin for respiratory distress syndrome in premature infants.
Approval decision date: March 6, 2012
This is Discovery's fifth attempt at convincing FDA to approve Surfaxin.

Roche (RHHBY) and Curis (CRIS)
Drug/indication: Vismodegib for advanced basal cell carcinoma.
Approval decision date: March 8, 2012.

MAP Pharmaceuticals (MAPP)
Drug/indication: Levadex for migraines
Approval decision date: March 26, 2012
Levadex is an inhaled migraine drug. FDA has not yet announced whether it intends to hold an advisory panel to review Levadex.

Chelsea Therapeutics (CHTP)
Drug/indication: Northera for orthostatic hypotension
Approval decision date: March 28, 2012

Pfizer (PFE) and Bristol-Myers Squibb (BMY)
Drug/indication: Eliquis for prevention of stroke and blood clots in patients with atrial fibrilation.
Approval decision date: March 28, 2012

Onyx Pharmaceuticals (ONXX)
Drug/indication: Carfilzomib for multiple myeloma
Approval decision date: March 28, 2012 (estimated, not confirmed, based on Sept. 28, 2011 filing date.
FDA accepted the carfilzomib filing on Nov. 28 but has not yet set a specific approval decision date. I'm assuming a six-month priority review because carfilzomib is a cancer drug.

Vivus (VVUS)
Drug/indication: Qnexa for obesity
Approval decision date: April 17, 2012
FDA rejected Qnexa initially in 2010 due to safety concerns.

Vertex Pharmaceuticals (VRTX)
Drug/indication: Kalydeco for cystic fibrosis
Approval decision date: April 19, 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 2012 (Specific date unknown.)
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)
Drug/indication: Avanafil for erectile dysfunction.
Approval decision date: April 29, 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

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

Sources: Company reports, TheStreet research, BioMedTracker.com

--Written by Adam Feuerstein in Boston.



>To contact the writer of this article, click here: Adam Feuerstein.

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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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