IMPAX Receives FDA Approval for Generic Aralen

November 02, 2003

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: