IMPAX Receives FDA Approval for Generic Urispas

August 29, 2003

HAYWARD, Calif.--(BUSINESS WIRE)--Aug. 29, 2003--IMPAX Laboratories, Inc. (Nasdaq:IPXL - News) today announced that the U.S. Food and Drug Administration (FDA) has granted approval to the Company's Abbreviated New Drug Application (ANDA) for a generic version of Urispas® (Flavoxate Hydrochloride) 100 mg tablets. Ortho McNeil Pharmaceutical, Inc. markets Urispas for the symptomatic relief of various urinary tract conditions including dysuria, urgency, nocturia, suprapubic pain, frequency and incontinence as may occur in cystitis, prostatitis, urethritis, urethrocystitis and urethrotrigonitis. According to NDCHealth, U.S. sales of Urispas were $8 million for the 12 months ended June 30, 2003. IMPAX's Global Pharmaceuticals division will begin marketing the product immediately.

"This is our third ANDA approval this year," said Larry Hsu, Ph.D. IMPAX's President. "We are pleased to add Flavoxate Hydrochloride Tablets to our growing portfolio of products. As the first generic version of Urispas, this product will offer both patients and payors a cost-effective alternative to the brand."

IMPAX currently has 19 applications pending at the FDA, including three tentatively approved that address approximately $7.1 billion in U.S. branded product sales for the twelve months ended June 30, 2003. Fifteen 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 specialty 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. Additionally, where strategically appropriate, IMPAX has developed marketing partnerships to fully leverage its technology platform. 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: