IMPAX Receives Final FDA Approval for a Generic Version of Claritin-D 12-Hour

January 31, 2003
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: