Drug/indication:Update to the Tysabri prescribing label
Approval decision date: Jan. 20, 2012
The Tysabri label update will include information about the anti-JC virus antibody status as a factor to help stratify the risk of progressive multifocal leukoencephalopathy (PML). Doctors can use to test to determine which multiple sclerosis patients are at low or high risk for PML, a serious, potentially fatal brain infection caused by Tysabri.
Drug/indication:progesterone vaginal gel for risk reduction of preterm birth.
FDA advisory panel: Jan. 20, 2012
Approval decision date:Feb. 26, 2012
Drug/indication: Bydureon for diabetes
Approval decision date: Jan. 27, 2012
This is the second shot at approval for Bydureon, a once-weekly injectable medicine for the treatment of Type 2 diabetes. Amylin recently split with its long-time marketing partner Eli Lilly (LLY). Alkermes (ALKS) retains its royalty split on Bydureon sales.
Drug/indication: dapagliflozin for diabetes
Approval decision date: Jan. 27, 2012
Drug/indication: Uplyso for Gaucher's disease.
Approval decision date: Feb. 1, 2012
FDA has twice-rejected Uplyso due to manufacturing and quality control issues. If approved this time around, Uplyso will compete against Sanofi/Genzyme's (SNY) Cerezyme and Shire's Vpriv. Teva (TEVA) and BioSante Pharmaceuticals (BPAX)
Drug/indication: Bio-T-Gel for hypogonadism
Approval decision date: Feb. 14, 2012
Bio-T-Gel is a once-daily gel used to treat low testosterone in men. Corcept Pharmaceuticals (CORT)
Drug/indication: Corlux for Cushing's Syndrome.
Approval decision date: Feb. 17, 2012
FDA will not convene an advisory panel to review Corlux. Discovery Labs (DSCO - Get Report)
Drug/indication: Surfaxin for respiratory distress syndrome in premature infants.
Approval decision date: March 6, 2012
This is Discovery's fifth attempt at convincing FDA to approve Surfaxin. Roche (RHHBY) and Curis (CRIS)
Drug/indication: Vismodegib for advanced basal cell carcinoma.
Approval decision date: March 8, 2012. MAP Pharmaceuticals (MAPP)
Drug/indication: Levadex for migraines
Approval decision date: March 26, 2012
Levadex is an inhaled migraine drug. FDA has not yet announced whether it intends to hold an advisory panel to review Levadex. Chelsea Therapeutics (CHTP)
Drug/indication: Northera for orthostatic hypotension
Approval decision date: March 28, 2012 Pfizer (PFE) and Bristol-Myers Squibb (BMY)
Drug/indication: Eliquis for prevention of stroke and blood clots in patients with atrial fibrilation.
Approval decision date: March 28, 2012 Onyx Pharmaceuticals (ONXX)
Drug/indication: Carfilzomib for multiple myeloma
Approval decision date: March 28, 2012 (estimated, not confirmed, based on Sept. 28, 2011 filing date.
FDA accepted the carfilzomib filing on Nov. 28 but has not yet set a specific approval decision date. I'm assuming a six-month priority review because carfilzomib is a cancer drug. Vivus (VVUS - Get Report)
Drug/indication: Qnexa for obesity
Approval decision date: April 17, 2012
FDA rejected Qnexa initially in 2010 due to safety concerns. Vertex Pharmaceuticals (VRTX)
Drug/indication: Kalydeco for cystic fibrosis
Approval decision date: April 19, 2012
Kalydeco is the first drug to treat the underlying cause of cystic fibrosis in patients with a specific genetic defect. Cell Therapeutics (CTIC - Get Report)
Drug/indication: pixantrone for non-Hodgkin's lymphoma
Approval decision date: April 2012 (Specific date unknown.)
Cell Therapeutics appealed the FDA's 2009 decision to reject pixantrone, setting up the drug's second chance at U.S. approval. Amgen (AMGN)
Drug/indication: Xgeva for prevention of bone metastases from prostate cancer.
Approval decision date: April 26, 2012 VVUS (VVUS - Get Report)
Drug/indication: Avanafil for erectile dysfunction.
Approval decision date: April 29, 2012 Merck (MRK) and Ariad Pharmaceuticals (ARIA)
Drug/indication: ridaforolimus for sarcoma.
Approval decision date: June 5, 2012 Ironwood Pharmaceuticals (IRWD)
Drug/indication: linaclotide for irritable bowel syndrome.
Approval decision date: June 8, 2012 Amarin (AMRN - Get Report)
Drug/indication: AMR101 for dyslipidemia.
Approval decision date: July 26, 2012 Sources: Company reports, TheStreet research, BioMedTracker.com --Written by Adam Feuerstein in Boston.
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