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Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic Version of Paxil(R)

Posted on: Tuesday, 3 July 2007, 12:33 CDT

DETROIT, July 3 /PRNewswire-FirstCall/ -- Caraco Pharmaceutical Laboratories, Ltd., announced today that the US Food and Drug Administration (FDA) has granted final approval for the Company's Abbreviated New Drug Application (ANDA) for paroxetine hydrochloride tablets, USP (Paroxetine HCl).

Paroxetine HCl is a psychotropic drug, which is indicated for the treatment of major depressive disorder, panic disorder, obsessive compulsive disorder, social anxiety disorder, generalized anxiety disorder, and posttraumatic stress disorder. Our generic paroxetine is the bioequivalent to Paxil(R), a registered trademark of GlaxoSmithKline. According to IMS Data, for the twelve months ended March 2007, paroxetine HCl generic and brand products (Paxil(R)) had annual sales of approximately $330 million. Caraco has four strengths available, 10mg, 20mg, 30mg and 40mg tablets.

Daniel H. Movens, Caraco's Chief Executive Officer, said, "We are pleased to gain this approval as it complements our portfolio and fortifies our product offering by expanding our product line. We plan to market this product to the generic pharmaceutical market immediately. This will bring our total product selection to 34 different products represented by 70 various strengths."

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.

CONTACT: Daniel Movens or Mukul Rathi, +1-313-871-8400, or Aaron Miles,+1-313-556-4150, all of Caraco Pharmaceutical Laboratories, Ltd.

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

Source: PRNewswire-FirstCall

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