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

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