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27 Hot Drugs Facing FDA Approval in 2012

NeurogesX (NGSX)
Drug/indication: Qutenza for HIV-associated peripheral neuropathy
FDA advisory panel: Feb. 9, 2012
Approval decision date: March 7, 2012

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.

Chelsea Therapeutics (CHTP)
Drug/indication: Northera for orthostatic hypotension
FDA advisory panel: Feb. 23, 2012 (tentative) Approval decision date: March 28, 2012

Vivus (VVUS), Arena Pharmaceuticals (ARNA) and Orexigen Therapeutics (VVUS)
Drugs/indication: Qnexa, lorcaserin and Contrave for obesity.
FDA advisory panel: The Endocrinologic and Metabolic Drugs Advisory Committee has tentative meetings scheduled for Feb. 22 and March 28-29, 2012.
FDA held advisory panels to review all three of these controversial weight-loss drugs in 2010. FDA subsequently rejected all three drugs. In 2012, Vivus and its obesity drug competitors are back for another shot, and FDA will once again bring together a group of outside experts to weigh the pros and cons of treating obesity with a pill.

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.

Affymax (AFFY)
Drug/indication:peginesatide for anemia in kidney dialysis patients.
Approval decision date:March 27, 2012
Peginesatide, injected once monthly, aims to compete against Amgen's (AMGN) Epogen ($2.5 billion in 2010 sales) as a treatment for anemia in patients with chronic kidney disease, although peginesatide use would be limited to sicker kidney dialysis patients only. On Dec. 7, an FDA advisory panel voted 15-1 to recommend peginesatide's approval.

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

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