Published in Drug Week, July 8th, 2005
The FDA's tentative approval is based upon its conclusion that Zolpidem ODT is safe and effective for use, according to the product labeling provided by Biovail. Final approval for Zolpidem ODT cannot be made effective until the expiration of patent protection for Ambien in October 2006, which is held by Sanofi-Aventis.
Zolpidem ODT is the first...
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