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: www.impaxlabs.com.