HAYWARD, Calif.--(BUSINESS WIRE)--Sept. 2, 2003--IMPAX Laboratories, Inc. (NASDAQ:
IPXL - News) today announced that the U.S. Food and Drug Administration (FDA)
has granted approval to the Company's Abbreviated New Drug Application (ANDA)
for a generic version of Aralen® (Chloroquine Phosphate) 500 mg tablets.
Sanofi Winthrop Pharmaceuticals markets Aralen for the suppressive treatment
and for acute attacks of malaria. According to NDCHealth, the U.S. market for
Chloroquine products was $3.4 million for the 12 months ended June 30, 2003.
IMPAX's Global Pharmaceuticals division will begin marketing the product in
the near future.
"This is our fourth ANDA approval this year," said Larry Hsu, Ph.D.,
IMPAX's President. "We are pleased to add Chloroquine Phosphate 500 mg
tablets to our product line. This product will complement the 250 mg strength
we are currently marketing."
IMPAX currently has 18 applications pending at the FDA, including three tentatively
approved, which address approximately $7.1 billion in U.S. branded product sales
for the twelve months ended June 30, 2003. Fifteen of these filings were made
under Paragraph IV of the Hatch-Waxman Amendments.
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 specialty 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. Additionally, where strategically appropriate, IMPAX has developed
marketing partnerships to fully leverage its technology platform. 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.