Second ANDA Approval of 2003 for IMPAX
Jan. 31, 2003--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) for a generic version of Claritin®-D 12-Hour
(Loratadine/Pseudoephedrine sulfate, 5mg/120mg) Extended Release Tablets. FDA
approved a switch in Claritin-D 12-Hour's status from a prescription drug to
an over-the-counter (OTC) drug for the relief of symptoms of seasonal allergic
rhinitis (hay fever) on December 9, 2002.
Under the terms of a non-exclusive Licensing, Contract Manufacturing and Supply
Agreement with Schering-Plough Corporation and a semi-exclusive Development,
License and Supply Agreement with Wyeth acting through its Wyeth Consumer Healthcare
Division, IMPAX will supply both companies for the OTC market. Shipment of the
product is expected to commence shortly.
"As we were the first company to file an ANDA with a Paragraph IV certification,"
said Larry Hsu, Ph.D. President of IMPAX Laboratories, "we have been awarded
180 days of marketing exclusivity commencing with the first commercial marketing."
After this approval, IMPAX has 19 applications pending at the FDA, including
four tentatively approved, that address approximately $5.8 billion in U.S. branded
product sales for the 12 months ended September 30, 2002. Fourteen of IMPAX's
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.