Biovail Drops On Non-Approval Letter For Smoking Treatment
July 23, 2007
| about: BVF
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Biovail Corp. (BVF) shares were in free fall Friday morning after the company announced it has received a non-approval letter from the U.S. Food and Drug Administration for its once-daily formulation of bupropion, a nicotine-free medication to stop smoking.
The FDA said that Biovail's studies to support the new drug application were not designed properly. Biovail, however, believes the studies were appropriate and will meet with the FDA as soon as possible to discuss necessary steps to resolve the situation, the company said in a statement.
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