Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Methimazole Tablets USP, 5 mg and 10 mg

    DETROIT, Sept. 26 /PRNewswire-FirstCall/ -- Caraco Pharmaceutical
 Laboratories, Ltd., ( CPD) announced today that the US Food and Drug
 Administration (FDA) has granted final approval for the Company's
 Abbreviated New Drug Application (ANDA) for Methimazole Tablets USP, 5 mg
 and 10 mg (Methimazole).
     Methimazole is indicated in the medical treatment of hyperthyroidism.
 Caraco's Methimazole is therapeutically equivalent to the FDA reference
 listed drug (RLD) listed in the Orange Book, Methimazole Tablets USP, 5 mg
 and 10 mg, respectively. According to IMS Data, for the twelve months ended
 June 2007, Methimazole had annual sales of approximately $21 million.
     Daniel H. Movens, Caraco's Chief Executive Officer, said, "We are
 pleased to receive this approval from the FDA. This marks the third
 approval in the last 30 days and the sixth approval this quarter. This is
 in addition to the two tentative approvals granted by the FDA during the
 period. One of the main driver's of our growth is to continue to expand and
 strengthen our product portfolio. This will bring our total product
 selection to 41 different products represented by 86 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.
 
 

SOURCE Caraco Pharmaceutical Laboratories, Ltd.