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.
-0- Sep/30/2003 14:00 GMT
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