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®, 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.
PondelWilkinson Inc.
Robert Jaffe/Evan Pondel
310-279-5980
