Biotech Calendar: 2011-12 FDA Drug Approvals

Updated with corrected FDA approval decision date for Roche's melanoma drug Zelboraf. It's Oct. 28, 2011, not Nov. 11, 2011, as previously reported.

BOSTON ( TheStreet) -- The 2011 FDA drug approval calendar has been updated and extended through the first quarter of 2012.

For easier reference, this regulatory calendar is organized in chronological order based on the drug approval decision date. Information on pending FDA advisory panels is also included.

Regeneron Pharmaceuticals ( REGN)
Drug/indication: Eyelea (VEGF Trap-Eye) for wet age-related macular degeneration
Approval decision date: Aug. 19, 2011
An FDA advisory panel in June voted to recommend Eyelea's approval.

Dendreon ( DNDN)
Drug/indication: Provenge for prostate cancer (Atlanta manufacturing expansion)
Approval decision date: Aug. 28, 2011

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

Seattle Genetics ( SGEN)
Drug/indication: Adcetris for Hodgkin's lymphoma and anaplastic large cell lymphoma (ALCL)
Approval decision date: Aug. 30, 2011

Alexion Pharmaceuticals ( ALXN)
Drug/indication: Soliris for Hemolytic Uremic Syndrome (HUS)
Approval decision date: Oct. 7, 2011
This would be the second approved indication for Soliris, which is already marketed as a treatment for paroxysymal nocturnal hemoglobinuria (PNH).

Bristol-Myers Squibb and AstraZeneca
Drug/indication: dapagliflozin for diabetes
Approval decision date: Oct. 28, 2011
An FDA advisory panel on July 19 voted to recommend against approval of dapagliflozin.

Pacira Pharmaceuticals ( PCRX)
Drug/indication: Exparel for post-surgical pain management
Approval decision date: Oct. 28, 2011

Roche ( RHHBY)
Drug/indication: Zelboraf for melanoma
Approval decision date: Oct. 28, 2011

Alimera Sciences ( ALIM)
Drug/indication: Iluvien for diabetic
Approval decision date: Nov. 11, 2011

Teva Pharmaceuticals ( TEVA) and BioSante Pharmaceuticals ( BPAX)
Drug/indication: Bio-T-Gel for male low testosterone levels
Approval decision date: Nov. 14, 2011

Spectrum Pharmaceuticals ( SPPI)
Drug/indication: Zevalin for non-Hodgkin's lymphoma (removal of Bioscan requirement)
Approval decision date: Nov. 20, 2011

Incyte ( INCY) and Novartis ( NVS)
Drug/indication: Ruxolitinib for myelofibrosis
Approval decision date: Dec. 3, 2011

Antares Pharma ( AIS)
Drug/indication: Anturol for overactive bladder
Approval decision date: Dec. 8, 2011

Pfizer
Drug/indication: crizotinib for non-small cell lung cancer
Approval decision date: Before end of 2011

Amylin Pharmaceuticals ( AMLN), Eli Lilly> ( LLY) and Alkermes> ( ALKS)
Drug/indication: Bydureon for diabetes
Approval decision date: Jan. 28, 2012

Alexza Pharmaceuticals ( ALXA)
Drug/indication: AZ-004 for schizophrenia-induced agitation
Approval decision date: Feb. 3, 2012

Corcept Therapeutics ( CORT)
Drug/indication: Corlux for Cushing's Syndrome
Approval decision date: Feb. 17, 2012

MAP Pharmaceuticals ( MAPP)
Drug/indication: Levadex for migraine
Approval decision date: March 26, 2012

Affymax ( AFFY) and Takeda
Drug/indication: peginesatide for anemia associated with chronic kidney disease
Approval decision date: March 27, 2012

Source: BioMedTracker, TheStreet research, company reports.

--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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