Caraco Pharmaceutical Laboratories, Ltd. Announces Tentative FDA Approval For Generic Lexapro(R)

Main Category: Depression
Also Included In: Regulatory Affairs / Drug Approvals;  Pharma Industry / Biotech Industry
Article Date: 01 Dec 2007 - 0:00 PDT

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Caraco Pharmaceutical Laboratories, Ltd., (Amex: CPD) announced 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 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.

Caraco Pharmaceutical Laboratories, Ltd.
http://www.caraco.com