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