FDAnews Drug Daily Bulletin

Endo Petitions FDA to Keep Opana Control as More ANDAs Are Submitted

Oct. 15, 2012
Endo Pharmaceuticals is petitioning the FDA to require generics referencing its crush-resistant pain drug, Opana ER CRF, demonstrate they are similarly crush-resistant. The company also wants the FDA to refuse to OK and withdraw any currently approved ANDAs that reference the noncrush-resistant formulation of Opana ER, which Endo no longer markets. Endo’s two citizen petitions, the most recent posted online Sept. 27, come as the company announced that two more generic-makers, Teva and Amneal, have submitted ANDAs with Paragraph IV certifications for Opana ER (oxymorphone HCl).
Washington Drug Letter