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Caraco Pharmaceutical Laboratories, Ltd. (CPD) to Market Generic Depakote(R) Delayed Release Tablets


7/30/2008 9:30:23 AM

DETROIT, July 30 /PRNewswire-FirstCall/ -- Caraco Pharmaceutical Laboratories, Ltd. announced today, that it has launched divalproex sodium delayed release tablets on behalf of Sun Pharmaceutical Industries Ltd. (Sun Pharma). Sun Pharma recently received approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for generic Depakote(R) delayed release tablets.

Divalproex sodium delayed release tablets are indicated as monotherapy and adjunctive therapy in the treatment of patients with complex partial seizures, as sole and adjunct therapy for patients with simple and complex absence seizures, for the treatment of the manic episodes associated with bipolar disorders, as well as for prophylaxis of migraine headaches. These generic versions of divalproex sodium delayed release 125 mg, 250 mg, and 500 mg (valproic acid activity) tablets are bioequivalent to Depakote(R) delayed release tablets distributed by Abbott Laboratories. According to IMS Data, Depakote(R) had US. sales of approximately $750 million for the 12-month period ended March 2008.

Depakote(R) is a registered trademark of Abbott Laboratories.

Detroit-based Caraco Pharmaceutical Laboratories, Ltd., develops, manufactures, markets and distributes generic and private-label pharmaceuticals to the nation's largest wholesalers, distributors, drugstore chains and managed care providers.

Safe Harbor: This news release contains forward-looking statements made pursuant to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995. Such statements are based on management's current expectations and are subject to risks and uncertainties that could cause actual results to differ materially from those described in the forward- looking statements. These risks and uncertainties are contained in the Corporation's filings with the Securities and Exchange Commission and include, but are not limited to: information of a preliminary nature that may be subject to adjustment, potentially not obtaining or delay in obtaining FDA approval for new products, governmental restrictions on the sale of certain products, development by competitors of new or superior products or cheaper products or new technology for the production of products, the entry into the market of new competitors, market and customer acceptance and demand for new pharmaceutical products, availability of raw materials, timing and success of product development and launches, dependence on few products generating majority of sales, product liability claims for which the Company may be inadequately insured, and other risks identified in this report and from time to time in our periodic reports and registration statements. These forward- looking statements represent our judgment as of the date of this report. We disclaim, however, any intent or obligation to update our forward-looking statements.

CONTACT: Daniel Movens, +1-313-871-8400, or Thomas Versosky,
+1-313-556-4150, both of Caraco Pharmaceutical

Web site: http://www.caraco.com/



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