IMPAX Receives FDA Approval To Market Fludrocortisone Acetate Tablets

March 19, 2002
Company's Sixth ANDA Approval

March 19, 2002 -- IMPAX Laboratories, Inc. (Nasdaq:IPXL) today announced that the U.S. Food and Drug Administration (FDA) has approved the Company's Abbreviated New Drug Application (ANDA) to market Fludrocortisone Acetate Tablets, a generic version of Florinef®.

The Company believes this is the first approval by the FDA of a generic version of Florinef. Florinef, which is marketed by Monarch Pharmaceuticals, a division of King Pharmaceuticals, as partial replacement for primary and secondary adrenocortical insufficiency in Addison's disease, had sales of approximately $27 million in the U.S. during 2001. IMPAX's Global Pharmaceuticals division will begin marketing the product immediately.

``This is our sixth ANDA approval and the first one this year,'' said Larry Hsu, Ph.D., IMPAX's President and COO. ``We are pleased to add Fludrocortisone Acetate Tablets to our growing portfolio of products. As the first generic version of Florinef, this product will offer both patients and payors a cost effective alternative to the brand.''

IMPAX currently has 14 Abbreviated New Drug Application (ANDA) filings pending at the FDA that address more than $8 billion in U.S. branded product sales during 2001. Nine of these filings were made under Paragraph IV of the Hatch-Waxman Amendments, one of which has received 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