FDA tentatively approves Wockhardt's anti-epileptic Divalproex Sodium delayed-release tablets

By Lisa Kerner

Charlotte, N.C., June 14 - The Food and Drug Administration tentatively approved Wockhardt Ltd.'s anti-epileptic drug, Divalproex Sodium delayed-release tablets, the generic version of Abbott's Depakote DR tablets, according to a company news release.

This will be Wockhardt's first product incorporating a novel drug delivery system cleared for sale in the United States.

Wockhardt plans to launch its product on Jan. 29, 2008, the date the Divalproex Sodium patent expires.

According to IMS data, the U.S. market for the product is $802 million.

Wockhardt is a technology-driven pharmaceutical and biotechnology company located in Mumbai, India.

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