DETROIT, Dec. 5 /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 Amlodipine Besylate Tablets, 2.5 mg, 5 mg, and 10 mg (Amlodipine).
Amlodipine is indicated for the treatment of hypertension, for the symptomatic treatment of chronic stable angina, and for the treatment of confirmed or suspected vasospastic angina. Amlodipine is the bioequivalent to Norvasc(R), a registered trademark of Pfizer Inc. According to IMS Data, based upon the most recent quarterly sales ended September 2007, Amlodipine generic and brand products combined have a run rate of approximately $550 million with ten generic competitors.
Daniel H. Movens, Caraco’s Chief Executive Officer, said, “This product marks our seventh final approval since June 30, 2007. We are evaluating the market place and internal production planning in an effort to monetize this approval as soon as possible. This will bring our total product selection to 43 different products represented by 92 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.
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/
