IMPAX Laboratories, Inc. has begun commercial distribution of its generic version of OxyContin (Oxycodone Hydrochloride) Controlled Release 80 mg Tablets. The product is being sold under the Global label and marketed by IMPAX's Global Pharmaceuticals division.

The US FDA granted final approval to the company's Abbreviated New Drug Application in late September 2004. IMPAX agreed not to market the product until FDA deemed the Company's Risk Management Programme (RMP) acceptable. The Company's revised RMP now is acceptable to the regulatory agency, the company release said here.

Purdue Pharma markets OxyContin for the management of moderate to severe pain. According to NDCHealth, US sales of OxyContin Controlled Release 80 mg Tablets and its generic equivalent were $677 million for the 12 months ended December 31, 2004.

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.