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Generic Version of OxyContin Gains Approval

HAYWARD, Calif.--(BUSINESS WIRE)--Sept. 28, 2004--IMPAX Laboratories, Inc. (Nasdaq:IPXL - News) announced that the U.S. Food and Drug Administration (FDA) has granted final approval to the Company's Abbreviated New Drug Application (ANDA) for a generic version of OxyContin® (Oxycodone Hydrochloride) Controlled Release 80mg Tablets. Purdue Pharma markets OxyContin for the management of moderate to severe pain. According to NDCHealth, U.S. sales of OxyContin Controlled Release 80mg Tablets and its generic equivalent were $688 million for the 12 months ended July 31, 2004.

Included in communications with the FDA related to the final approval is a commitment by the Company not to launch the product until a revised Risk Management Program (RMP) has been submitted to, and is found acceptable by, the FDA. A revised RMP has recently been submitted to the FDA by the Company.

"This is our tenth ANDA approval this year, which exceeds our full year total of nine in 2003," commented Barry R. Edwards, Chief Executive Officer of IMPAX. "We received tentative approval for the product late in 2003 and had anticipated final approval following the expiration of marketing exclusivity for the first ANDA filer. Operationally, we have been making preparations for a market launch, but because of outstanding issues, including pending patent infringement litigation by Purdue, a final decision on timing has not yet been made," Mr. Edwards continued.

Source: Impax Laboratories

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