IMPAX Receives FDA Tentative Approval of Fenofibrate ANDA

February 21, 2002
IMPAX's First Tentative Approval of an ANDA with a Paragraph IV Filing

February 21, 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 Tricor® (Fenofibrate Capsules), Micronized. Tricor is marketed by Abbott Laboratories, Inc. (NYSE:ABT - news) for the treatment of very high serum triglyceride levels. According to IMS Health, U.S. sales of the capsule form of the prescription lipid-regulating agent were over $235 million in 2001. Abbott has announced the discontinuation of the capsule form and its replacement by a new tablet form.

The tentative approval covers Fenofibrate Capsules (Micronized) 67 mg, 134 mg and 200 mg capsules. Final approval is contingent upon the earlier of (1) the settlement of pending patent-infringement litigation brought by Abbott against IMPAX, or (2) the expiration of the 30-month stay process under the Hatch-Waxman Amendments; and the expiration of any generic marketing exclusivity. Final approval is also dependent upon FDA's evaluation of any new information subsequent to this tentative approval.

IMPAX Laboratories announced FDA acceptance of the Company's ANDA filing for Fenofibrate in July 2000, and commented on the filing of a lawsuit by Abbott Laboratories alleging patent infringement relating to the ANDA in September 2000.

``We are delighted to receive this notification for Fenofibrate Capsules (Micronized), our first tentative approval of an ANDA containing a Paragraph IV certification,'' said Larry Hsu, Ph.D., President and Chief Operating Officer. ``Upon resolution of the tentative approval provisions, our generic version of Tricor® will be marketed in the U.S. by our Global Pharmaceuticals division.''

IMPAX currently has 15 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 and one of these now has tentative approval from 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: