Caraco Pharmaceutical Laboratories Ltd. Announces FDA Approval to Market Generic Ambien(R)
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- Published on Tuesday, 24 April 2007 04:00
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DETROIT, MI, USA | Apr 23, 2007 | Caraco Pharmaceutical Laboratories, Ltd., (Amex: CPD) announced today that the US Food and Drug Administration (FDA) has granted final approval for the Company's Abbreviated New Drug Application (ANDA) for Zolpidem Tartrate Tablets.
Zolpidem Tartrate is a sedative-hypnotic drug, which is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. This new product is the bioequivalent to Ambien(R), a registered trademark of Sanofi-aventis. Ambien(R) had U.S. sales of approximately $2.09 billion for the 12-month period ended Dec. 31, 2006, according to IMS Data. Caraco has two strengths available, 5 mg and 10 mg tablets.
Daniel H. Movens, Caraco's Chief Executive Officer, said, "An essential part of our core business strategy is to broaden our portfolio by expanding our product offerings. This is our first sedative-hypnotic product and we are pleased that this will complement our current portfolio. We plan to launch this product to the market immediately. This will bring our total product selection to 29 different products represented by 65 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.
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.
SOURCE: Caraco Pharmaceutical Laboratories Ltd.