FDA accepts Endo's resubmission for Opana ER
CHADDS FORD, Pa. — The Food and Drug Administration has accepted a resubmission by Endo Pharmaceuticals of a regulatory application for an opioid pain drug designed to thwart abuse, Endo said.
The agency had declined to approve Endo’s Opana ER (oxymorphone hydrochloride) in January for reasons that the company did not specify, though the agency did not request additional clinical studies in its statement, known as a complete response letter.
The drug is designed to prevent abuse by being resistant to crushing, which drug abusers often do with opioid painkillers so they can snort or inject them.
The agency plans to take action on the resubmission in December.