Caraco Pharmaceutical Laboratories Receives FDA Approval
For Tizanidine Hydrochloride Formulary Rises to 18 Drugs Two Additional Drugs Pending FDA Approval
DETROIT, Sept. 30 /PRNewswire-FirstCall/ -- Caraco Pharmaceutical Laboratories, Ltd. (Amex: CPD) has received approval from the U.S. Food and Drug Administration (FDA) to manufacture and market tizanidine hydrochloride, a generic form of Elan Pharmaceutical's Zanaflex, Narendra N. Borkar, Chief Executive Officer, announced today.
Tizanidine is a short-acting muscle relaxant prescribed for the management of spasticity and has a U.S. market of approximately $240 million.
He noted that the Company has two additional drugs pending FDA approval.
Detroit-based Caraco Pharmaceutical Laboratories, Ltd., develops, manufactures and distributes generic and private-label prescription drugs to some of the nation's largest wholesalers, distributors, drugstore chains, healthcare systems and state and federal agencies.
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: information is of a preliminary nature and may be subject to further adjustment, not obtaining or delays in obtaining FDA approval for new products, governmental restrictions on the sale of certain products, dependence on key personnel, 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, integrity and reliability of the Corporation's data, lack of success of attaining full compliance with regard to regulatory and cGMP compliance, and other risks identified from time to time in the Corporation's reports and registration statements filed with the SEC, available free via EDGAR. The Corporation assumes no responsibility to update forward-looking statements.
SOURCE Caraco Pharmaceutical Laboratories, Ltd.
/CONTACT: Narendra Borkar, Jitendra Doshi, or Bob Kurkiewicz of Caraco Pharmaceutical, +1-313-871-8400; or Mike Marcotte of Marcotte Financial Relations, +1-248-656-3873, for Caraco Pharmaceutical Laboratories, Ltd./
CO: Caraco Pharmaceutical Laboratories, Ltd. ST: Michigan IN: MTC SU:
-0- Sep/30/2003 14:00 GMT