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Article: ViroPharma Prepares To Receive Not Approvable' Picovir Letter.
- Article from:
- BIOWORLD Today
- Article date:
- November 4, 2009
CopyrightCOPYRIGHT 2009 A Thomson Healthcare Company. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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Washington Editor
The FDA is not expected to grant ViroPharma Inc. regulatory clearance for its cold medicine that has been criticized for reducing the duration of illness by only one day.
ViroPharma, of Exton, Pa., and its partner, Aventis Pharmaceuticals, of Bridgewater, N.J., released a brief statement late Thursday saying the FDA intends to issue a "not approvable" letter by May 31 in reference to the new drug application (NDA) for Picovir.
ViroPharma's stock (NASDAQ:VPHM) took the news hard Friday, falling 92 cents, or 21.7 percent, to close at $3.33. The company's stock was trading at $13.41 in March before the FDA's Antiviral Drugs ...