IMPAX Receives FDA Tentative Approval for a Generic Version of Claritin-D 24-Hour

May 29, 2002
IMPAX's Second Tentative Approval of a Paragraph IV ANDA Filing

May 29, 2002 -- IMPAX Laboratories, Inc. (Nasdaq:IPXL) today announced that the U.S. Food and Drug Administration (FDA) has granted tentative approval to the Company's Abbreviated New Drug Application (ANDA) for a generic version of Claritin-D® 24-Hour (loratadine/pseudoephedrine sulfate, 10mg/240mg) Extended Release Tablets.

Claritin-D® 24-Hour is marketed by Schering-Plough Corporation for the relief of symptoms of seasonal allergic rhinitis (hay fever). According to IMS Health, U.S. sales of the tablets were approximately $539 million for the twelve months ended March 31, 2002.

Final approval is contingent upon the earlier of (1) the resolution of pending patent-infringement litigation brought by Schering-Plough against IMPAX, or (2) the expiration of the 30-month stay process under the Hatch-Waxman Amendments; and the expiration of any generic marketing exclusivity. Final approval is also dependent upon FDA's evaluation of any new information subsequent to this tentative approval.

IMPAX Laboratories announced FDA acceptance of the Company's ANDA filing for Loratadine and Pseudoephedrine Sulfate Extended Release Tablets, 10mg/240mg (24-hour formulation) in November 2000 and commented on the filing of a lawsuit by Schering Corporation alleging patent infringement relating to the ANDA in January 2001.

"We are very pleased to receive this notification for Loratadine and Pseudoephedrine Sulfate Extended Release Tablets, 10mg/240mg (24-hour formulation), our second tentative approval of an ANDA containing a Paragraph IV certification," said Larry Hsu, Ph.D., President and Chief Operating Officer. "We continue to make progress both in submitting new ANDAs, as well as in moving our pending ANDAs through the FDA review process toward commercialization."

IMPAX currently has 15 ANDA filings pending at the FDA that address more than $8 billion in U.S. branded product sales. Nine of these filings were made under Paragraph IV of the Hatch-Waxman Amendments, and two of these now have tentative approval from FDA.

IMPAX Laboratories, Inc. is a technology focused 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: