Drug/indication: Kalydeco for cystic fibrosis
Approval decision date: April 18, 2012
Kalydeco is the first drug to treat the underlying cause of cystic fibrosis in patients with a specific genetic defect.
Drug/indication: pixantrone for non-Hodgkin's lymphoma
Approval decision date: April 24, 2012
Cell Therapeutics appealed the FDA's 2009 decision to reject pixantrone, setting up the drug's second chance at U.S. approval.
Drug/indication: Xgeva for prevention of bone metastases from prostate cancer.
Approval decision date: April 26, 2012
Drug/indication: Avanafil for erectile dysfunction.
Approval decision date: April 29, 2012
Drug/indication: Uplyso for Gaucher's disease.
Approval decision date: May 1, 2012
FDA has twice-rejected Uplyso due to manufacturing and quality control issues and delayed a third decision from February to May. If approved this time around, Uplyso will compete against Sanofi/Genzyme's (SNY) Cerezyme and Shire's Vpriv. Talon Therapeutics (TLON)
Drug/indication: Marquibo for acute lymphoblastic leukemia (ALL)
Approval decision date: May 13, 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 Navidea Biopharmaceuticals (NAVB)
Drug/indication: Lymphoseek, a lymph node tracing agent.
Approval decision date: June 10, 2012 Amarin (AMRN)
Drug/indication: AMR101 for dyslipidemia.
Approval decision date: July 26, 2012 Horizant Pharmaceuticals (HZNT)
Drug/indication: Lodotra for rheumatoid arthritis
Approval decision date: July 26, 2012 Onyx Pharmaceuticals (ONXX)
Drug/indication: carfilzomib for multiple myeloma
Approval decision date: July 27, 2012 Sources: Company reports, TheStreet research, BioMedTracker.com --Written by Adam Feuerstein in Boston.
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