BOSTON (TheStreet) -- An early Christmas present for biotech investors: The first (overstuffed) FDA drug approval calendar of 2011.
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.
In all, this calendar contains drug approval and regulatory milestone information on 34 drug and biotech stocks for 2011.
Drug/indication: Afrezza for diabetes
Approval decision date: Dec. 29, 2010
This is the second review cycle for Afrezza, a small, inhaled insulin device for diabetes.
Alimera Sciences (ALIM) and pSivida (PSDV)
Drug/indication: Iluvien for diabetic macular edema
Approval decision date: Dec. 30, 2010
Drug/indication: Zictifa for medullary thyroid cancer
Approval decision date: Jan. 7, 2011
An FDA advisory panel on Dec. 2 gave conditional support to the approval of Zictifa, also recommending that a post-approval study be conducted to determine if a lower dose could reduce side effects while maintaining efficacy.
Clinical Data (CLDA)
Drug/indication: Vilazodone for major depressive disorder
Approval decision date: Jan. 22, 2011
Orexigen Therapeutics (OREX)
Drug/indication: Contrave for obesity
Approval decision date: Jan. 31, 2011
An FDA advisory panel held Dec. 7 voted 13-7 to recommend Contrave's approval.
Bristol-Myers Squibb (BMY)
Drug/indication: Yervoy (ipilimumab) for melanoma
FDA advisory panel meeting: Feb. 9, 2011
Approval decision date: March 26, 2011
Both the FDA advisory panel meeting and the FDA's approval decision date for Yervoy were pushed back from December after Bristol submitted additional clinical data. Bristol is seeking initial approval for ipilimumab for patients who have previously received treatment for melanoma.
Pfizer (PFE) and Protalix Biotherapeutics (PLX)
Drug/indication: Uplyso for Gaucher's disease
Approval decision date: Feb. 25, 2011
Salix Pharmaceuticals (SLXP)
Drug/indication: Xiafaxan 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.
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