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The accompanying table includes an updated calendar of expected FDA new product decisions with over 70 entries as a follow-up to my previous article on pending clinical trial results.
Click here for a link to my previous FDA calendars and the companies listed below have expected decisions within the next month or decisions which are overdue for a ruling by the agency.
1) Schering-Plough (SGP): Saphris (asenapine) – nearly three months overdue
2) Genzyme (GENZ): Synvisc-One – received recommendation for approval by advisory panel – about three weeks overdue
3) Cypress Bioscience (CYPB) + Forest Labs (NYSE:FRX) – about three months overdue for milnacipran decision in treatment of fibromyalgia
4) Eli Lilly (NYSE:LLY) + Daiichi Sankyo (OTC:DSKYY) – A 2/3/09 FDA Advisory Panel Meeting is scheduled for Effient (prasugrel) to discuss the blood thinner drug candidate which would compete with multi-billion dollar blockbuster Plavix.
5) Hologic (NASDAQ:HOLX) + KV Pharma (KV-A) – Gestiva NDA ruling expected 1/25/09
6) LLY + Amylin Pharma (AMLN) – An overdue decision for Byetta as mono-therapy for Type 2 diabetes is expected in early 2009
7) King Pharma (KG) – An overdue decision for abuse-resistant pain drug Embeda (morphine) is expected in early 2009
8) Pfizer (NYSE:PFE) and Ligand (NASDAQ:LGND) – A decision is expected by the end of the month for Fablyn.
9) Sanofi-Aventis (NYSE:SNY) - A decision is expected by the end of the month for Multaq.
10) GTC Biotherapeutics (GTCB) – A decision is expected by 2/7/09 for the BLA for Atryn, which would represent the world's first therapeutic from genetically engineered animals (goats). An FDA advisory panel voted that Atryn is safe and effective and recommended it for approval.