IMPAX Receives Tentative FDA Approval for Generic Version of Tricor Tablets; Fourth ANDA Approval of 2004

March 8, 2004

HAYWARD, Calif.--(BUSINESS WIRE)--March 8, 2004--IMPAX Laboratories, Inc. (Nasdaq:IPXL) announced that the U.S. Food and Drug Administration (FDA) has granted tentative approval to the Company's Abbreviated New Drug Application (ANDA) for its generic version of Tricor(R) (Fenofibrate) Tablets. Tricor Tablets are marketed by Abbott Laboratories, Inc. (NYSE:ABT) to assist patients in managing their cholesterol levels. The drug is indicated for use in reducing elevated LDL cholesterol, total cholesterol, triglycerides and Apo B and increasing HDL cholesterol in patients with primary hypercholesterolemia or mixed lipidemia. The drug has also been approved as adjunctive therapy for the treatment of hypertriglyceridemia, a disorder characterized by elevated levels of very low density lipoprotein (VLDL) in the plasma. According to NDCHealth, U.S. sales of Tricor Tablets were approximately $590 million for the 12 months ended December 31, 2003.

Final FDA approval is contingent upon the earlier of the resolution of pending patent-infringement litigation brought by Abbott against IMPAX, or 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.

"This is our fourth ANDA approval this year and reflects the strength of both our R&D and Regulatory teams," said Larry Hsu, Ph.D., IMPAX's President. "We are pleased to see our new product pipeline continue to progress through FDA."

The FDA accepted for review IMPAX's Fenofibrate Tablets application in December 2002. IMPAX's submission included a Paragraph IV certification stating that, to the Company's knowledge, the product does not infringe upon Abbott's listed Tricor Tablet patents or that they are invalid. Abbott Laboratories (NYSE:ABT) has filed lawsuits against the Company in the federal district court in Delaware alleging patent infringement related to IMPAX's filing of its ANDA for Fenofibrate Tablets. These lawsuits are ongoing.

IMPAX currently has 19 applications pending at the FDA, including six tentatively approved, which address approximately $6.8 billion in U.S. branded product sales for the twelve months ended December 31, 2003. Fourteen 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:

"Safe Harbor" statement under the Private Securities Litigation Reform Act of 1995:

To the extent any statements made in this news release contain information that is not historical, these statements are forward-looking in nature and express the beliefs and expectations of management. Such statements are based on current expectations and involve a number of known and unknown risks and uncertainties that could cause IMPAX's future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Such risks and uncertainties include, but are not limited to, IMPAX's ability to obtain sufficient capital to fund its operations, the difficulty of predicting FDA filings and approvals, consumer acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, IMPAX's ability to successfully develop and commercialize pharmaceutical products, IMPAX's reliance on key strategic alliances, the uncertainty of patent litigation, the availability of raw materials, the regulatory environment, dependence on patent and other protection for innovative products, exposure to product liability claims, fluctuations in operating results and other risks detailed from time to time in IMPAX's filings with the Securities and Exchange Commission. Forward-looking statements speak only as to the date on which they are made, and IMPAX undertakes no obligation to update publicly or revise any forward-looking statement, regardless of whether new information becomes available, future developments occur or otherwise.

    CONTACT: Company Contacts:
             IMPAX Laboratories, Inc.
             Barry R. Edwards, 215-289-2220, Ext. 1771
             Larry Hsu, 510-476-2000, Ext. 1111
             Cornel C. Spiegler, 215-289-2220, Ext. 1706
             Investor Relations Contacts:
             Lippert/Heilshorn & Associates, Inc.
             Kim Sutton Golodetz, 212-838-3777
             Bruce Voss, 310-691-7100

    SOURCE: IMPAX Laboratories, Inc.