Lannett Company Receives Approval For Dipyridamole Tablets USP, 25 Mg, 50 Mg, And 75 Mg

Main Category: Blood / Hematology
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 28 Apr 2008 - 1:00 PDT

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Lannett Company, Inc. (AMEX:LCI), a manufacturer of generic pharmaceuticals, announced that it has received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Dipyridamole Tablets USP, 25mg, 50mg, and 75mg, the generic equivalent of Persantine® Tablets manufactured by Boehringer Ingelheim GmbH. According to Wolters Kluwer, total sales of generic Dipyridamole Tablets were $46 million a year in 2007 at average wholesale price (AWP).

Dipyridamole Tablets are indicated as an adjunct to coumarin anticoagulants in the prevention of postoperative thromboembolic complications of cardiac valve replacement.

"As we enter our 66th year of providing low cost alternative generic drugs, we welcome this new addition to our line," said Arthur Bedrosian, President and CEO of Lannett. "We expect to commence marketing all three dosages of our Dipyridamole product in this quarter."

Lannett Company

Lannett Company, founded in 1942, develops, manufactures, packages, markets and distributes generic pharmaceutical products for a wide range of indications. For more information, visit Lannett Company's website at http://www.lannett.com.

This news release contains certain forward-looking statements, which express the current beliefs and expectations of management. Such statements are based on current expectations and involve a number of known and unknown risks and uncertainties that could cause Lannett's future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include Lannett's ability to successfully commercialize Dipyridamole Tablets, successfully develop products, the impact of competition from brand name companies that sell their own generic products or successfully extend the exclusivity period of their branded products, the availability of product liability coverage in the current insurance market, the impact of pharmaceutical industry regulation and pending legislation that could affect the pharmaceutical industry, the difficulty of predicting U.S. Food and Drug Administration and other regulatory authority approvals, acceptance and demand for new pharmaceutical products and new therapies, uncertainties regarding market acceptance of innovative products newly launches, currently being sold or in development, the impact of restructuring of clients, reliance on strategic alliances, exposure to product liability claims, dependence on patent and other protections for innovative products, fluctuations in currency, exchange and interest rates, operating results and other factors that are discussed in Lannett's Annual Report on Form 10K for its fiscal year ended June 30, 2007 and its other filings with the U.S. Securities and Exchange Commission. Forward-looking statements speak only as of t he date on which they are made, and the Company undertakes no obligation to update publicly or revise any forward-looking statement, whether as a result of new information, future developments or otherwise.

Lannett Company