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) - Get Regeneron Pharmaceuticals, Inc. Report

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) - Get UIPATH INC Report

Drug/indication:

Zelrix, a skin patch for migraines.

Approval decision date:

Aug. 29, 2011

Seattle Genetics

(SGEN) - Get Seagen, Inc. (SGEN) Report

Drug/indication:

Adcetris for Hodgkin's lymphoma and anaplastic large cell lymphoma (ALCL)

Approval decision date:

Aug. 30, 2011

Alexion Pharmaceuticals

(ALXN) - Get Alexion Pharmaceuticals, Inc. Report

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) - Get Pacira Biosciences, Inc. Report

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) - Get Alimera Sciences, Inc. Report

Drug/indication:

Iluvien for diabetic

Approval decision date:

Nov. 11, 2011

Teva Pharmaceuticals

(TEVA) - Get Teva Pharmaceutical Industries Limited Sponsored ADR Report

and

BioSante Pharmaceuticals

(BPAX)

Drug/indication:

Bio-T-Gel for male low testosterone levels

Approval decision date:

Nov. 14, 2011

Spectrum Pharmaceuticals

(SPPI) - Get Spectrum Pharmaceuticals, Inc. Report

Drug/indication:

Zevalin for non-Hodgkin's lymphoma (removal of Bioscan requirement)

Approval decision date:

TheStreet Recommends

Nov. 20, 2011

Incyte

(INCY) - Get Incyte Corporation (INCY) Report

and

Novartis

(NVS) - Get Novartis AG Sponsored ADR Report

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) - Get Eli Lilly and Company (LLY) Report

and

Alkermes

>

(ALKS) - Get Alkermes Plc Report

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) - Get Corcept Therapeutics Incorporated. Report

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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