73 Decision Dates on Updated FDA Calendar

Nov. 22, 2008 1:12 PM ETTARG, INVA, VNDA, JNJ, GSK, LGND, AMGN, BHC4 Comments
Mike Havrilla profile picture
Mike Havrilla
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The accompanying table (click to enlarge) includes an updated calendar of 75 expected FDA decision dates as part of the ETF Innovators (ETFI) New Drug Regulatory Catalyst Index, which includes a full slate of expected action before year-end outlined in my previous article. The last few days have been busy for antibiotics at the agency, resulting in sharply lower stock prices for Targanta Therapeutics (TARG) and Theravance (THRX).

An FDA panel voted against Targanta's oritavancin, which has an upcoming decision in early December and sent shares crashing from 8 bucks before the decision to around $1.30 in trading on Friday. Despite the panel endorsement for telavancin, shares of Theravance lost about 25% Friday and the company is still waiting for the FDA to issue a formal PDUFA date.

Vanda Pharma (VNDA) received word yesterday from the FDA that its resubmission for iloperidone was accepted with a decision date expected by 5/6/09. Some other recent filings include Ista Pharma's (ISTA) NDA for eye drop Bepreve and two new filings by Johnson & Johnson (JNJ) for Comfyde and trabectedin.

On a positive note, GlaxoSmithKline (GSK) and Ligand Pharma (LGND) received approval late on Thursday for Promacta to treat a rare condition known as chronic immune thrombocytopenic purpura in which a patient's immune system attacks platelets, resulting in easy bruising and bleeding episodes. The drug will compete with Amgen's (AMGN) Nplate, which was approved for the same condition back in August but required injections as compared to Promacta which is taken by mouth.

An additional approval was won by JNJ earlier today for an adult pain medication called tapentadol, which is pending classification by the DEA as a controlled substance before it can be marketed.

This article was written by

Mike Havrilla profile picture
3.07K Followers
Mike Havrilla earned Doctor of Pharmacy (PharmD) and Bachelor of Science (Biology) degrees from the University of Pittsburgh and is a licensed pharmacist and investor.

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