IMPAX Receives FDA Approval for Generic Flumadine

September 3, 2002
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: