Caraco Pharmaceutical Laboratories, Ltd. Announces Tentative FDA Approval for Zolpidem Tartrate
DETROIT, Aug. 23 /PRNewswire-FirstCall/ — Caraco Pharmaceutical Laboratories, Ltd. announced today that the US Food and Drug Administration (FDA) has granted tentative approval for the Company’s ANDA for Zolpidem Tartrate, 5mg and 10mg tablets. Final approval of this product is anticipated subsequent to the expiry of patent protection in October 2006.
Caraco’s Zolpidem Tartrate is the generic equivalent of Sanofi’s short- term treatment of insomnia product, Ambien(R).
“We are extremely pleased with receiving this tentative approval and look forward to the expiration date of the patent in October 2006, allowing Caraco to market the product,” said Daniel H. Movens, Chief Executive Officer.
“This tentative approval will be a positive addition to our current portfolio of products,” he added.
Total annual US sales of the brand product for both strengths are approximately $2.0 billion for all indications.
Caraco operates an R&D Center at its Detroit headquarters complex and receives R&D support from Sun Pharmaceutical Industries, Ltd., India’s fifth largest pharmaceutical firm.
Detroit-based Caraco Pharmaceutical Laboratories, Ltd., develops, manufactures and distributes generic and private-label prescription drugs to the nation’s wholesalers, distributors, drugstore chains and healthcare systems.
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 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, experiencing difficulty in managing our recent rapid growth and anticipated future growth, dependence on limited customer base, occasional credits to certain customers reflecting price reductions on products previously sold to them and still available as shelf- stock, possibility of an incorrect estimate of charge-backs and the impact of such an incorrect estimate on net sales, gross profit and net income, dependence on few products generating majority of sales, product liability claims for which the Company may be inadequately insured, subjectivity in judgment of management in applying certain significant accounting policies derived based on historical experience, terms of contracts, our observations of trends of industry, information received from our customers and other sources, to estimate revenues, accounts receivable allowances including chargebacks, rebates, income taxes, values of assets and inventories, litigation involving claims of patent infringement, litigation involving claims for royalties relating to a prior contract for one product and other risks identified in this report and identified from time to time in our reports and registration statements filed with the Securities and Exchange Commission. 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 Jitendra Doshi of Caraco Pharmaceutical,+1-313-871-8400; or Mike Marcotte of Marcotte Financial Relations,+1-248-656-3873