IMPAX Receives FDA Approval for Omeprazole, a Generic Version of Prilosec

November 11, 2002
Final Approval for 10 and 20 mg Strengths, Tentative Approval for 40 mg Strength

November 11, 2002 -- IMPAX Laboratories, Inc. (Nasdaq NM: IPXL) today announced that the U.S. Food and Drug Administration (FDA) has granted final approval to the Company's Abbreviated New Drug Application (ANDA) for its 10 and 20 mg strengths and tentative approval for its 40 mg strength of Omeprazole Delayed Release Capsules, a generic version of Prilosec®. AstraZeneca markets Prilosec for the treatment of duodenal/gastric ulcers and GERD (gastro-esophageal reflux disease). According to IMS Health, U.S. sales of Prilosec were approximately $4.2 billion for the twelve months ended June 30, 2002.

Final FDA approval of the Company's 40 mg strength of Omeprazole Delayed Release Capsules is contingent upon the earlier of (1) the resolution of pending patent-infringement litigation brought by AstraZeneca 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.

"We are pleased with FDA's approval of our Omeprazole ANDA. This product is representative of our development strategy of applying our formulation and development expertise to create significant generic opportunities," said Larry Hsu, Ph.D., President and Chief Operating Officer of IMPAX Laboratories. "This is our seventh ANDA approval this year including those tentatively approved by the FDA."

"Our lawsuit with AstraZeneca is still pending in the courts," said Barry R. Edwards, Co-Chief Executive Officer. "We are awaiting word from the judge regarding the timing of our case moving forward. We remain confident in our defenses with respect to AstraZeneca's patents."

After this approval, IMPAX has 19 ANDAs pending at the FDA that address more than $5.6 billion in U.S. branded product sales for the twelve months ended June 30, 2002. Eleven of these filings were made under Paragraph IV of the Hatch-Waxman Amendments. Four of these 19 pending ANDAs, as well as one strength of one approved ANDA, have received tentative approval from the FDA.

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 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: