Drug Development

U.S. FDA grants tentative approval of Zolpidem ODT for sleep disorders

Published in Drug Week, July 8th, 2005

Biovail Corporation (BVF)announced that it has received tentative approval from the United States Food and Drug Administration (FDA) for its New Drug Application (NDA) for its oral disintegrating tablet (ODT) formulation of zolpidem tartrate, which is indicated for the short-term treatment of insomnia.

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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Source: Drug Week (2005-07-08)

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