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 www.impaxlabs.com.