IMPAX's Second ANDA Approval This Year
September 3, 2002 -- IMPAX Laboratories, Inc. (Nasdaq NM: IPXL) today
announced that the U.S. Food and Drug Administration (FDA) has granted approval
of the Company's Abbreviated New Drug Application (ANDA) for a generic version
of Flumadine® (Rimantadine Hydrochloride 100mg) tablets. Forest Laboratories,
Inc. markets Flumadine for the prevention and treatment of illness caused by
various strains of influenza A virus in adults. This is the second FDA approval
of an ANDA for generic Rimantadine. According to IMS Health, U.S. sales of Rimantadine
products were $7.2 million for the 12 months ended June 30, 2002. This product
will be marketed through the Company's Global Pharmaceuticals division.
"This is our second ANDA approval this year, and we are pleased with the
progress we are making in our development and commercialization strategy,"
said Larry Hsu, Ph.D., President and Chief Operating Officer of IMPAX Laboratories.
"The development of our generic version of Flumadine® is consistent
with our strategy to develop niche products we believe will have limited competition."
IMPAX currently has 16 ANDA filings pending at the FDA that address more than
$9 billion in U.S. branded product sales. Ten of these filings were made under
Paragraph IV of the Hatch-Waxman Amendments, and four of these 16 ANDAs have
received tentative approval from the FDA.
IMPAX Laboratories, Inc. is a technology based specialty pharmaceutical company
applying its formulation expertise and drug delivery technology to the development
of controlled-release and niche generics in addition to the development of branded
products. IMPAX markets its generic products through its Global Pharmaceuticals
division and intends to market its branded products through the IMPAX Pharmaceuticals
division. IMPAX Laboratories is headquartered in Hayward, California, and has
a full range of capabilities in its Hayward and Philadelphia facilities. For
more information, please visit the Company's Web site at: www.impaxlabs.com.