IMPAX Receives FDA Approval for Generic Rilutek

January 30, 2003

Jan. 30, 2003--IMPAX Laboratories, Inc. (NASDAQ:IPXL) today announced that the U.S. Food and Drug Administration (FDA) has granted final approval to the Company's Abbreviated New Drug Application (ANDA) for a generic version of Rilutek® (Riluzole 50mg) tablets. Aventis markets Rilutek® for the treatment of amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease. Approval followed the expiration of Aventis' Orphan Drug Exclusivity on December 12, 2002. According to IMS Health, U.S. sales of Rilutek were $35 million for the 12 months ended September 30, 2002.

The Company also announced that on December 12, 2002, the District Court of Wilmington, Delaware, granted the preliminary injunction motion brought by Aventis on October 15, 2002, to forestall IMPAX's entry into this market. The Company had sought a declaratory judgment action seeking a judicial declaration of invalidity against Aventis regarding patent 5,527,814 that was only recently listed by Aventis in the FDA "Orange Book." Litigation is currently scheduled for trial in October 2003.

"We are pleased that the FDA has granted final approval of the Company's generic version of Rilutek and look forward to making a lower-cost product available to patients suffering from ALS," commented Larry Hsu, Ph.D., President of IMPAX Laboratories. "Despite the granting of the preliminary injunction to Aventis, we remain optimistic about the eventual outcome of this patent validity challenge."

After this approval, IMPAX has 20 ANDAs pending at the FDA, including four tentatively approved, that address more than $6.1 billion in U.S. branded product sales for the 12 months ended September 30, 2002. Fourteen 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: