Biovail Corporation has received tentative approval from the United States Food and Drug Administration 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 labelling 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, the release said.

Zolpidem ODT is the first Biovail formulation tentatively approved by the FDA that utilizes Biovail's patented Ceform technology.

"For some people who experience daytime sleepiness and impaired performance as a result of transient insomnia, the short-term use of short-acting medication for sleep disorders may improve sleep and, in turn, next-day alertness," said Dr. Douglas Squires, Chief Executive Officer of Biovail Corporation. "Given that insomnia tends to occur more frequently in patients over the age of 60, we believe that our ODT version of zolpidem tartrate will provide health-care practitioners, upon final approval, with another viable treatment option to treat transient and intermittent sleep difficulties," he added.

Biovail expects to enter into an agreement with a strategic partner for the marketing and distribution of the product in the US. Subject to regulatory approvals, Biovail anticipates it will manufacture and supply all the partner company's trade and sample supply requirements. At this time, the FDA is willing to allow Biovail to choose a trademark prior to the commercialization of the product.

Zolpidem is currently marketed in the US under the brand name, Ambien, by Sanofi-Aventis. The patent, which is held by Sanofi-Aventis, expires in October 2006. Therefore, Sanofi-Aventis can effectively block commercialization of Biovail's Zolpidem ODT prior to this date.