IMPAX Receives Final FDA Approval for Generic Version of OxyContin in 10mg, 20mg and 40mg Strengths; Sixth Approval in 2005

December 6, 2005

HAYWARD, Calif.--(BUSINESS WIRE)--Dec. 6, 2005--IMPAX Laboratories, Inc. (OTC:IPXL) today announced that the U.S. Food and Drug Administration (FDA) has granted final approval to the Company's Abbreviated New Drug Application for a generic version of OxyContin(R) (Oxycodone Hydrochloride) Controlled Release 10mg, 20mg, and 40mg Tablets. Purdue Pharma markets OxyContin for the management of moderate to severe pain. According to NDCHealth, U.S. sales of OxyContin Controlled Release 10mg, 20mg, and 40mg Tablets and its generic equivalent were $1.2 billion for the 12 months ended September 2005. IMPAX intends to begin marketing this product immediately through its previously announced exclusive supply and distribution agreement with DAVA Pharmaceuticals, Inc. DAVA will have exclusive sales and distribution rights in the United States and Puerto Rico and IMPAX will be responsible for all manufacturing and regulatory aspects.

"We are pleased to have received this approval, our sixth of 2005," said Larry Hsu, Ph.D., IMPAX's president. "This is a significant complement to our existing 80mg business and with it, we and our marketing partner will be able to provide a more comprehensive offering for patients suffering from moderate to severe pain."

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, possible adverse effects resulting from the delisting of IMPAX's stock, IMPAX's delay in filing its 2004 Form 10-K and its Form 10-Q's for the first two quarters of 2005, 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: IMPAX Laboratories, Inc.
Barry R. Edwards, 215-933-0360
Larry Hsu, Ph.D., 510-476-2000, Ext. 1111
Arthur Koch, 215-933-0351
Investor Relations Contacts:
Lippert/Heilshorn & Associates, Inc.
Kim Sutton Golodetz, 212-838-3777
Bruce Voss, 310-691-7100

SOURCE: IMPAX Laboratories, Inc.