DETROIT, July 20 /PRNewswire-FirstCall/ -- Caraco Pharmaceutical Laboratories, Ltd., announced today that the US Food and Drug Administration (FDA) has granted tentative approval for the Company’s Abbreviated New Drug Application (ANDA) for Modafinil Tablets (modafinil), 100mg and 200mg.
Modafinil is indicated to improve wakefulness in patients with excessive sleepiness associated with narcolepsy. This new product is the bioequivalent to Provigil(R), a registered trademark of Cephalon, Inc. Provigil(R) tablets had U.S. sales of approximately $753 million for the 12-month period ended March 31, 2007, according to IMS Data.
Daniel H. Movens, Caraco’s Chief Executive Officer, said, “We are extremely pleased to receive this tentative approval. Modafinil was filed with a paragraph IV certification that we do not infringe and or that the Cephalon patent is invalid. We were not sued by Cephalon. We looked forward to marketing this product subsequent to the expiration of the patent and exclusivity period.”
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/
