Caraco Pharmaceutical Laboratories, Ltd. Announces Tentative FDA Approval for Generic ...( DETROIT Nov. 30 /- Caraco Pharmac...),Health

DETROIT, Nov. 30 /PRNewswire-FirstCall/ -- Caraco Pharmaceutical Laboratories, Ltd., (Amex: CPD) announced today that the US Food and Drug Administration (FDA) has granted tentative approval for the Company's Abbreviated New Drug Application (ANDA) for Escitalopram Oxalate Tablets (escitalopram), 5 mg, 10 mg, and 20 mg.

Escitalopram is indicated for the treatment of major depressive disorder. This tentative approval is for the generic bioequivalent product to Lexapro(R), which is offered by Forest Laboratories, Inc. Lexapro(R) tablets had U.S. sales of approximately $2.5 billion for the 12-month period ending on September 30, 2007, according to IMS Data.

Daniel H. Movens, Caraco's Chief Executive Officer, said, "We are extremely pleased to receive this tentative approval. The ANDA was filed with a Paragraph IV certification that we do not infringe Forest's Lexapro(R) patents or that they are invalid. As previously disclosed, we are currently involved in litigation with Forest Laboratories that will determine whether we may launch our generic product prior to the expiration of these patents. Though the outcome of this litigation is uncertain, we remain confident in our position and continue to expect a favorable conclusion."

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
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