Healthcare Industry News:  Eisai 

Biopharmaceuticals Generics FDA

 News Release - May 8, 2009

Lannett Company Receives FDA Approval for Pilocarpine HCI Tablets 7.5 mg Strength

PHILADELPHIA--(HSMN NewsFeed)--Lannett Company, Inc. (AMEX: LCI ), a manufacturer of generic pharmaceuticals, today announced that it has received approval from the U.S. Food and Drug Administration (FDA) of its supplemental Abbreviated New Drug Application (ANDAs) for Pilocarpine HCI tablets, 7.5 mg, the generic equivalent of Salagen(R), marketed by Eisai Pharmaceuticals. Lannett previously received and currently markets Pilocarpine HCI tablets, in the 5 mg strength. According to Wolters Kluwer, sales in 2008 of both generic and brand Pilocarpine HCI 7.5 mg tablets were $2.5 million at Average Wholesale Price.

Pilocarpine HCI tablets are indicated for 1) the treatment of symptoms of dry mouth from salivary gland hypofunction caused by radiotherapy for cancer of the head and neck; and 2) the treatment of symptoms of dry mouth in patients with Sjogren’s syndrome.

“This approval adds an important dosage strength to our Pilocarpine product offering,” said Arthur Bedrosian, president and chief executive officer of Lannett. “We are now able to offer our customers one stop shopping for both strengths.”

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 commercialize Pilocarpine HCI Tablets, 7.5 mg strength, 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, 2008 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.


Source: Lannett Company

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