DETROIT, July 30 Caraco PharmaceuticalLaboratories, Ltd. (Amex: CPD) announced today, that it has launcheddivalproex sodium delayed release tablets on behalf of Sun PharmaceuticalIndustries Ltd. (Sun Pharma). Sun Pharma recently received approval from theUS 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 andadjunctive therapy in the treatment of patients with complex partial seizures,as sole and adjunct therapy for patients with simple and complex absenceseizures, for the treatment of the manic episodes associated with bipolardisorders, as well as for prophylaxis of migraine headaches. These genericversions of divalproex sodium delayed release 125 mg, 250 mg, and 500 mg(valproic acid activity) tablets are bioequivalent to Depakote(R) delayedrelease tablets distributed by Abbott Laboratories. According to IMS Data,Depakote(R) had US. sales of approximately $750 million for the 12-monthperiod 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-labelpharmaceuticals to the nation's largest wholesalers, distributors, drugstorechains and managed care providers.
Safe Harbor: This news release contains forward-looking statements madepursuant to the safe-harbor provisions of the Private Securities LitigationReform Act of 1995. Such statements are based on management's currentexpectations and are subject to risks and uncertainties that could causeactual results to differ materially from those described in the forward-looking statements. These risks and uncertainties are contained in theCorporation's filings with the Securities and Exchange Commission and include,but are not limited to: information of a preliminary nature that may besubject to adjustment, potentially not obtaining or delay in obtaining FDAapproval for new products, governmental restrictions on the sale of certainproducts, development by competitors of new or superior products or cheaperproducts or new technology for the production of products, the entry into themarket of new competitors, market and customer acceptance and demand for newpharmaceutical products, availability of raw materials, timing and success ofproduct development and launches, dependence on few products generatingmajority of sales, product liability claims for which the Company may beinadequately insured, and other risks identified in this report and from timeto time in our periodic reports and registration statements. These forward-looking statements represent our judgment as of the date of this report. Wedisclaim, however, any intent or obligation to update our forward-lookingstatements.
SOURCE Caraco Pharmaceutical Laboratories, Ltd.