FDA Approves Teva's Generic OxyContin

Law360, New York (December 12, 2004, 12:00 AM EST) -- Federal regulators have granted tentative approval to a low-dose generic version Purdue Pharma LP's OxyContin pain reliever to Israeli drug maker Teva Pharmaceutical Industries Ltd.

Teva said the approval applies to 10-, 20- and 40-milligram extended release tablets of the oxycodone hydrochloride drug. The company previously received approval from the U.S. Food and Drug Administration for an 80-milligram version of OxyContin and began shipping that product on March 30.

Teva received 6 months exclusivity for the 80-milligram version of OxyContin and launched the product "at-risk," meaning...
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