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 (
) -- 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 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)
Drug/indication:
Zelrix, a skin patch for migraines.
Approval decision date:
Aug. 29, 2011
Seattle Genetics
(SGEN) - Get Report
Drug/indication:
Adcetris for Hodgkin's lymphoma and anaplastic large cell lymphoma (ALCL)
Approval decision date:
Aug. 30, 2011
Alexion Pharmaceuticals
(ALXN) - Get 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 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 Report
Drug/indication:
Iluvien for diabetic
Approval decision date:
Nov. 11, 2011
Teva Pharmaceuticals
(TEVA) - Get 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 Report
Drug/indication:
Zevalin for non-Hodgkin's lymphoma (removal of Bioscan requirement)
Approval decision date:
Nov. 20, 2011
Incyte
(INCY) - Get Report
and
Novartis
(NVS) - Get 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 Report
and
Alkermes
>
(ALKS) - Get 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 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:
,
TheStreet
research, company reports.
--Written by Adam Feuerstein in Boston.
>To contact the writer of this article, click here:
Adam Feuerstein
.
>To follow the writer on Twitter, go to
http://twitter.com/adamfeuerstein
.
>To submit a news tip, send an email to:
.
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;
to send him an email.
