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Biotech Calendar: 2011 FDA Drug Approvals

Stocks in this article: HGSIOPTRXNPTSPPIDRRXPATH

Xenoport (XNPT) and GlaxoSmithKline (GSK)
Drug/indication: Horizant for restless leg syndrome
Approval decision date: April 6, 2011
This is the second FDA review cycle for Horizant. The original new drug application was filed to FDA in January 2009.

Spectrum Pharmaceuticals (SPPI)
Drug/indication: Fusilev for colon cancer
Approval decision date: April 29, 2011
This is the second review for Fusilev in colon cancer. The drug is already approved as a treatment for a form of bone cancer.

Merck (MRK)
Drug/indication: Boceprevir for Hepatitis C
Approval decision date:May 2011
Merck will not disclose the exact FDA approval decision date, but it's likely the first two weeks of May. An FDA advisory panel scheduled for April 27-28 is a likely venue for a boceprevir review.

Vertex Pharmaceuticals (VRTX)
Drug/indication: Telaprevir for Hepatitis C
Approval decision date: May 23, 2011
An FDA advisory panel scheduled for April 27-28 is a likely venue for a telaprevir review.

King Pharmaceuticals (KG) and Acura Pharmaceuticals (ACUR)
Drug/indication: Acurox, an abuse-resistant, immediate-release opioid.
Approval decision date: June 17, 2011

Pain Therapeutics (PTIE), Durect Corp. (DRRX) and King Pharmaceuticals (KG)
Drug/indication:: Remoxy, a abuse-resistant opioid for moderate to severe pain.
Approval decision date: June 23, 2011

Seattle Genetics (SGEN)
Drug/indication: brentuximab vedotin for Hodgkin's lymphoma
Approval decision date: Third quarter 2011 (estimated, based on the company's forecast for a first-quarter 2011 approval filing.)

Transcept Pharmaceuticals (TSPT)
Drug/indication: Intermezzo for insomnia
Approval decision date: July 14, 2011
This is the second FDA review for Intermezzo following a complete response letter in October 2009.

NuPathe (PATH)
Drug/indication: Zelrix, a transdermal patch for migraines.
Approval decision date: Aug. 29, 2011

Adventrx Pharmaceuticals (ANX)
Drug/indication: ANX-530 (exelbine) for non-small cell lung cancer
Approval decision date: Sept. 1, 2011
ANX-530 is a reformulation of the generic chemotherapy drug vinorelbine. The FDA issued a refuse-to-file letter for ANX-530 in 2010.

MELA Sciences (MELA)
Device/indication: MELAFind for diagnosis of melanoma
Approval decision date: Unknown
FDA rejected MELAFind in March 2010 but an FDA advisory panel in November narrowly recommended the device's approval over the FDA's objection. The FDA has not said when it will issue another approval decision for MELAFind.


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