HAYWARD, Calif.--(BW HealthWire)--July 22, 2002--IMPAX Laboratories, Inc. (Nasdaq:IPXL) today announced that the U.S. Food and Drug Administration (FDA) has granted tentative approval to the Company's Abbreviated New Drug Application (ANDA) for a generic version of Rilutek(R) (Riluzole 50mg) tablets. Aventis Pharmaceutical Products, Inc. markets Rilutek(R) for the treatment of amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease. According to IMS Health, U.S. sales of Rilutek were $35 million for the 12 months ended March 31, 2002.

Final FDA approval is contingent upon the expiration of Orphan Drug Exclusivity on December 12, 2002, resolution of the patent litigation that IMPAX has initiated against Aventis regarding a patent recently listed by Aventis in the FDA "Orange Book," as well as FDA's evaluation of any new information subsequent to this tentative approval.

"This is our fourth ANDA tentative 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 Rilutek(R) is consistent with our strategy to develop niche products we believe will have limited competition. Upon final approval, we anticipate that our Global Pharmaceuticals division will market the product."

For more information, please visit the Company's Web site at: www.impaxlabs.com.