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发帖数: 12 | 1 Biotech Calendar: 2011 FDA Drug Approvals
05/25/11
BOSTON (TheStreet) -- The 2011 FDA drug approval calendar has been updated.
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.
Optimer Pharmaceuticals(OPTR_)
Drug/indication: Dificid for Clostridium difficile infection
FDA approval decision date: May 30, 2011
GlaxoSmithKline(GSK_) and Valeant Pharmaceuticals(VRX_)
Drug/indication: Potiga for partial seizures due to epilepsy
FDA approval decision date: June 14, 2011
Glaxo and Valeant submitted on April 15 a response to the FDA's complete
response letter for Potiga which was delivered on Nov 30, 2010.
Bristol-Myers Squibb(BMY_)
Drug/indication: belatacept for kidney transplant rejection
FDA approval decision date: June 15, 2011
FDA initially rejected belatacept in May 2010.
Pfizer(PFE_) and Acura Pharmaceuticals(ACUR_)
Drug/indication: Acurox, an abuse-resistant, immediate-release opioid.
Approval decision date: June 17, 2011
Regeneron Pharmaceuticals(REGN_)
Drug/indication: VEGF Trap-Eye for wet age-related macular degeneration
FDA advisory meeting: June 17, 2011
Approval decision date: Aug. 20, 2011
Salix Pharmaceuticals(SLXP_)
Drug/indication: Xifaxan for irritable bowel syndrome (IBS)
FDA meeting: June 20, 2011
Xiafaxan is already approved for travelers' diarrhea and hepatic
encephalopathy but FDA rejected the drug for IBS in March, requesting
additional retreatment data. Salix is expected to update investors on the
timeline for Xifaxan's IBS resubmission following the June 20 meeting with
FDA.
Fibrocell Science(FCSC.OB)
Drug/indication: laViv for treatment for nasolabial folds and wrinkles
Approval decision date: June 22, 2011
Pain Therapeutics(PTIE_), Durect Corp.(DRRX_) and Pfizer(PFE)
Drug/indication:: Remoxy, an abuse-resistant opioid for moderate to severe
pain.
Approval decision date: June 23, 2011
Dendreon(DNDN_)
Drug/indication: Provenge for prostate cancer (Orange County, Calif.
manufacturing expansion)
Approval decision date: June 30, 2011
Dendreon is seeking FDA approval to expand Provenge's manufacturing capacity
to a new facility in Southern California. A second, new manufacturing plant
in Atlanta is also under construction, expected to receive FDA approval in
late August or early September.
Cell Therapeutics(CTIC_)
Drug/indication: Pixantrone for aggressive non-Hodgkin's lymphoma
FDA meeting date: June 2011
Cell Therapeutics filed an appeal with FDA contesting the agency's April
2010 rejection of pixantrone. The company is meeting with FDA in early June
to discuss pixantrone resubmission plans.
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.
AstraZeneca(AZN_)
Drug/indication: Brilinta, a blood thinner used in patients with acute
coronary syndrome.
Approval decision date: July 20, 2011
FDA rejected Brilinta in December 2010.
Pacira Pharmaceuticals(PCRX_)
Drug/indication: Exparel for post-surgical pain management
Approval decision date: July 28, 2011
Gilead Sciences(GILD_)
Drug/indication: Btripla for HIV
Approval decision date: Aug. 10, 2011
Btripla is a single-pill treatment for HIV that combines Gilead's Truvada
with Johnson & Johnson's rilpivirine.
NuPathe(PATH_)
Drug/indication: Zelrix, a transdermal 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
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.
Corcept Therapeutics(CORT_)
Drug/indication: Corlux for Cushing's Syndrome
Approval decision date: Oct. 15, 2011 (tentative, based on April 15 FDA
filing date and request for a six-month priority review.)
Bristol-Myers Squibb and AstraZeneca
Drug/indication: dapagliflozin for diabetes
Approval decision date: Oct. 28, 2011
An FDA advisory panel may be convened on July 19 to review dapagliflozin.
Alimera Sciences(ALIM_) and pSivida(PSDV_)
Drug/indication: Iluvien for diabetic
Approval decision date: Nov. 13, 2011 (tentative, based on May 13
resubmission and expected six-month FDA review.)
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
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
Sources: BioMedTracker.com, TheStreet research and company reports. |
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