Impax Gets FDA OK For Generic Oxycontin

Law360, New York (September 28, 2004, 12:00 AM EDT) -- Federal regulators have granted Impax Laboratories Inc. approval for a generic version of the Purdue Frederick Company’s blockbuster painkiller Oxycontin Controlled Release in 80 milligram tablets, the generic drug maker said.

Impax has agreed not to launch the drug until the U.S. Food and Drug Administration (FDA) approves a revised risk management program, the company said.

Another generic drug maker, Endo Pharmaceuticals, expects to receive 180 days of marketing exclusivity with respect to 10mg, 20mg and 40mg strengths of the same drug. The company won that...
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