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Lannett Receives FDA Approval for Phentermine; Company to Launch Product Shortly
Business Wire, April 21, 2005
PHILADELPHIA -- Lannett Company, Inc. (Amex:LCI) today announced it has received approval from the U.S. Food and Drug Administration (FDA) for the Abbreviated New Drug Application (ANDA) of Phentermine Hydrochloride Tablets 37.5 mg. The company expects to commence marketing this product in June 2005.
Phentermine Hydrochloride is indicated for the short-term management of obesity and is the generic equivalent of Adipex-P(R), marketed by Gate Pharmaceuticals, a division of Teva Pharmaceutical Industries.
"Phentermine is the second product approval Lannett has received this year," said Arthur Bedrosian, president of Lannett. "Through the hard work and dedication of our research and development team, Lannett continues to build a robust pipeline. We currently have nine applications pending at the FDA and a number of other products in various stages of development that will further expand our product offering."
According to NDC Health, the total U.S. market for Phentermine Hydrochloride 37.5 mg tablets is approximately $84 million. Currently, there are five other generic suppliers marketing this product.
About 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 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 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, 2004 and its other filings with the U.S. Securities and Exchange Commission. Forward-looking statements speak only as of the 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.
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