IMPAX Receives FDA Approval To Market Fludrocortisone Acetate Tablets; Company's Sixth ANDA Approval.Business Editors/Health & Medical Writers HAYWARD, Calif.--(BW HealthWire)--March 19, 2002 IMPAX Laboratories, Inc. (Nasdaq:IPXL) today announced that the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) has approved the Company's Abbreviated New Drug Application abbreviated new drug application Pharmacology An application made in the US by a pharmaceutical company requesting authority to market a 'new' drug for which both its therapeutic indications and formulation were previously approved by the FDA in another similar (ANDA ANDA abbr. abbreviated new drug application ) to market Fludrocortisone Acetate flu·dro·cor·ti·sone acetate n. A synthetic mineralocorticoid used to increase blood pressure by lowering the amount of salt the body excretes and to treat adrenocortical insufficiency resulting from Addison's disease. Tablets, a generic version of Florinef(R). 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 (NYSE NYSE See: New York Stock Exchange :KG), as partial replacement for primary and secondary adrenocortical insufficiency secondary adrenocortical insufficiency n. Adrenocortical insufficiency caused by failure of ACTH secretion resulting from anterior pituitary disease or by ACTH inhibition resulting from exogenous steroid therapy. 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. "Safe Harbor" statement under the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and To the extent any statements made in this news release contain information that is not historical, these statements are essentially forward-looking and are subject to risks and uncertainties, including the difficulty of predicting FDA filings and approvals, acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, uncertainty of patent litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called litigation. filed against us, availability of raw materials, the regulatory environment, fluctuations in operating results and other risks detailed from time to time in the Company's filings with the Securities and Exchange Commission. |
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