IMPAX ANDA Filing for Generic Version of Allegra-D Accepted By FDA

February 12, 2002
Company's Eighth Paragraph IV ANDA Filing

February 12, 2002 -- IMPAX Laboratories, Inc. (Nasdaq:IPXL) today announced that the U.S. Food and Drug Administration (FDA) has accepted the Company's filing of an Abbreviated New Drug Application (ANDA) for a generic version of Allegra-D® (Fexofenadine HCl/Pseudoephedrine HCl) Extended Release 60 mg/120mg Tablets.

Aventis Pharmaceuticals Inc. markets Allegra-D® for the relief of symptoms associated with seasonal rhinitis in adults and children 12 years of age and older. U.S. sales of Allegra-D® Extended Release Tablets were over $350 million in 2001.

IMPAX's application includes a certification under Paragraph IV of the Hatch-Waxman Amendments stating the Company's belief that its product does not infringe Aventis Pharmaceuticals Inc.'s listed patents on Allegra-D® Extended Release Tablets. The FDA's acceptance of the ANDA for filing means that the agency has determined that the application is sufficiently complete so as to permit a review.

``This is our eighth filing of an ANDA under Paragraph IV with the FDA, and was our seventh filing in calendar year 2001,'' said Larry Hsu, Ph.D., President and Chief Operating Officer. ``With this filing, we continue to advance the pipeline of products that will drive our sales growth in the years to come. Looking forward, we have set a goal of filing between six and eight new ANDAs in 2002.''

IMPAX currently has fifteen ANDA filings pending at the FDA that address more than $8 billion in U.S. branded product sales. Nine 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 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: