DETROIT, Sept. 26 /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 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.
Caraco Pharmaceutical Laboratories, Ltd.
CONTACT: Daniel Movens, +1-313-871-8400, or Aaron Miles, +1-313-556-4150,both of Caraco Pharmaceutical Laboratories, Ltd.
Web site: http://www.caraco.com//
