12:00 AM
Sep 10, 2012
 |  BC Week In Review  |  Clinical News  |  Regulatory

Crush-resistant Opana ER oxymorphone regulatory update

Endo submitted 2 Citizen's Petitions to FDA asking the agency to require any ANDAs referencing pain drug Opana ER oxymorphone contain data and information demonstrating the generic is similarly crush-resistant as the reformulated Opana ER. Additionally, Endo asked the agency to determine...

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