Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic Version of Tenormin(R)
DETROIT, July 11 /PRNewswire-FirstCall/ -- Caraco Pharmaceutical Laboratories, Ltd., announced today that the US Food and Drug Administration (FDA) has granted final approval for the Company's Abbreviated New Drug Application (ANDA) for Atenolol Tablets USP (atenolol).
Atenolol is indicated in the management of hypertension, long-term management of patients with angina pectoris and in the management of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality. Our generic atenolol is the bioequivalent to Tenormin(R), a registered trademark of AstraZeneca Pharmaceuticals LP. According to IMS Data, for the twelve months ended March 2007, atenolol generic and brand products (Tenormin(R)) combined had annual sales of approximately $102 million. Caraco has three strengths available, 25mg, 50mg and 100mg tablets.
Daniel H. Movens, Caraco's Chief Executive Officer, said, "We are pleased to gain an approval from the FDA on this well established product used in managing hypertension. Our focus continues to be working towards expanding our product line effectively, including products that are already available generically in the market that potentially can add measurable value. We plan to market this product to the generic pharmaceutical market immediately. This will bring our total product selection to 35 different products represented by 73 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.
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//