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news.Impax Laboratories has begun commercial distribution of its generic version of Purdue Pharma's OxyContin tablets. The pain drug generic is being sold under the Global label and marketed by Impax' generics arm, the Global Pharmaceuticals division.
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The FDA granted final approval to the company’s abbreviated new drug application for the generic OxyContin (oxycodone hydrochloride) controlled release 80mg tablets in late September 2004. Impax agreed not to market the product until FDA deemed the company’s risk management program (RMP) acceptable, which it now does.
OxyContin is marketed by Purdue Pharma for the management of moderate to severe pain.
Impax expects product rollout to begin at a slow pace and grow over time. Due to ongoing litigation between Purdue and Endo, however, the launch could mean trouble in the future for Impax as, if a US court finds in favor of Endo, Impax could be liable for damages as a result of the product launch.