PHILADELPHIA -- (Business Wire)
Lannett Company, Inc. (NYSE AMEX: LCI) today announced that it has
received approval from the U.S. Food and Drug Administration (FDA) for
its Abbreviated New Drug Application (ANDA) of Diethylproprion HCl
Tablets, 25 mg. Diethylproprion HCl Tablets, 25 mg, is therapeutically
equivalent to the reference listed drug, Tenuate® Tablets, 25
mg, of Watson Pharmaceuticals. Retail pharmacy sales of Diethylproprion
HCl Tablets, 25 mg, at Average Wholesale Price (AWP) were approximately
$3.3 million for the year ending May, 2011, according to Wolters Kluwer.
Additional sales of this drug are made through bariatric clinics. The
company expects to commence shipping the product shortly.
“Recognizing the struggle that many have with losing weight, we are
pleased to offer Diethylproprion HCl Tablets, 25 mg, which further
rounds out our portfolio of anti-obesity treatments,” said Arthur P.
Bedrosian, president and chief executive officer of Lannett. “We have 16
ANDAs currently pending at the FDA and are optimistic that a number of
them will be approved in the coming months.”
Diethylproprion HCl is indicated in the management of exogenous obesity
as a short-term adjunct (a few weeks) in a regimen of weight reduction.
About Lannett Company, Inc.:
Lannett Company, founded in 1942, develops, manufactures, packages,
markets and distributes generic pharmaceutical products for a wide range
of indications. For more information, visit the company’s website at www.lannett.com.
This news release contains certain statements of a forward-looking
nature relating to future events or future business performance.Any
such statements, including, but not limited to,whether expressed
or implied, are subject to risks and uncertainties which can cause
actual results to differ materially from those currently anticipated due
to a number of factors which include, but are not limited to, the
successful commercialization of Diethylproprion HCl Tablets, 25 mg, the
difficulty in predicting the timing or outcome of FDA or other
regulatory approvals or actions, the ability to successfully
commercialize products upon approval, Lannett’s estimated or anticipated
future financial results, future inventory levels, future competition or
pricing, future levels of operating expenses, product development
efforts or performance, and other risk factors discussed in the
company’s Form 10-K and other documents filed with the Securities and
Exchange Commission from time to time.These forward-looking
statements represent the company's judgment as of the date of this news
release.The company disclaims any intent or obligation to update
these forward-looking statements.
Contacts:
PondelWilkinson Inc.
Robert Jaffe, 310-279-5980
Source: Lannett Company, Inc.
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