Biotech Calendar: 2011 FDA Drug Approvals

BOSTON ( TheStreet) -- I've updated the 2011 FDA drug approval calendar.

For easy reference, I've organized this regulatory calendar in chronological order based on the drug approval decision date. I've also included information on pending FDA advisory panels. At the end of the calendar is a list of companies with potential regulatory milestones in 2011 based on expected but not yet completed drug approval filings.

This FDA drug approval calendar updates and expands a similar calendar published in December.

Pfizer ( PFE) and Protalix Biotherapeutics ( PLX)
Drug/indication: Uplyso for Gaucher's disease
Approval decision date: Feb. 25, 2011

Salix Pharmaceuticals ( SLXP)
Drug/indication: Xifaxan for irritable bowel syndrome
Approval decision date: March 7, 2011
Xiafaxan is already approved for travelers' diarrhea and hepatic encephalopathy.

Human Genome Sciences ( HGSI)
Drug/indication: Benlysta for lupus
Approval decision date: March 10, 2011
If approved, Benlysta would be the first new drug for lupus patients in 50 years. GlaxoSmithKline ( GSK) will co-market Benlysta. The FDA's approval decision date was pushed back three months from Dec. 9, 2010.

Bristol-Myers Squibb ( BMY)
Drug/indication: Yervoy (ipilimumab) for melanoma
Approval decision date: March 26, 2011
FDA cancelled and has no plans to reschedule an advisory panel meeting originally set for Feb. 9. Bristol is seeking initial approval for ipilimumab for patients who have previously received treatment for melanoma.

Dendreon ( DNDN)
Drug/indication: Provenge for prostate cancer (manufacturing expansion)
Approval decision date: March 2011
Dendreon is seeking FDA approval to expand Provenge manufacturing capacity at its New Jersey facility. Two additional Provenge plants are under construction outside Atlanta and in Orange Country, Calif. that are expected to come on line in the middle of the year.

Cell Therapeutics ( CTIC)
Drug/indication: Pixantrone for aggressive non-Hodgkin's lymphoma
Approval decision date: First quarter 2011
Cell Therapeutics filed an appeal with FDA contesting the agency's April 2010 rejection of pixantrone.

Forest Laboratories ( FRX)
Drug/indication: Daxas for chronic obstructive pulmonary disorder
Approval decision date: First quarter 2011
This is the second FDA review cycle for Daxas.

Optimer Pharmaceuticals
Drug/indication: Fidaxomicin for Clostridium difficile infection
FDA advisory panel date: April 5, 2011
FDA approval decision date: May 30, 2011

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.

Additional drugs with potential regulatory milestones in 2011:

Onyx Pharmaceuticals ( ONXX)
Drug/indication: carfilzonib for multiple myeloma
Status: FDA approval filing expected mid-2011

Alimera Sciences ( ALIM) and pSivida ( PSDV)
Drug/indication: Iluvien for diabetic macular edema
Status: FDA rejected Iluvien in December; Alimera intends to resubmit for approval this year based on new, longer-term data.

Genzyme ( GENZ) and Isis Pharmaceuticals ( ISIS)
Drug/indication: mipomersen for severe hypercholesterolemia
Status: Genzyme is in the process of being acquired by Sanofi-Aventis, which may affect the regulatory timelines for mipomersen. Genzyme had previously suggested that the mipomersen approval filing could be delayed until the second half of 2011, from the previous estimate of a filing in the first half 2011.

MAP Pharmaceuticals ( MAPP)
Drug/indication: Levadex for migraines
Status: MAP intends to file for Levadex approval in the first half of 2011.

Vivus ( VVUS)
Drug/indication: Qnexa for obesity
Status: FDA rejected Qnexa in October. Vivus intends to resubmit Qnexa to FDA in 2011.

Amylin Pharmaceuticals ( AMLN), Alkermes ( ALKS) and Eli Lilly ( LLY)
Drug/indication: Bydureon for diabetes
Status: Additional clinical work required by FDA after October rejection is ongoing. Resubmission expected by end of 2011.

Alexza Pharmaceuticals ( ALXA)
Drug/indication: AZ-004 for agitation in patients with schizophrenia or bipolar disorder
Status: Alexza plans to resubmit AZ-004 to FDA in July 2011.

--Written by Adam Feuerstein in Boston.

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Adam Feuerstein writes regularly for TheStreet.com. In keeping with TSC's editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet.com. 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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