Endo Pharmaceuticals, Inc.; Withdrawal of Approval of a New Drug Application for OPANA (Oxymorphone Hydrochloride) Extended-Release Tablets

الملخص

The Food and Drug Administration (FDA) is withdrawing approval of the new drug application (NDA) for OPANA (oxymorphone hydrochloride) extended-release (ER) tablets (NDA 201655), held by Endo Pharmaceuticals, Inc., 1400 Atwater Dr., Malvern, PA 19355 (Endo). Endo requested that the approval of this application be withdrawn and has waived its opportunity for a hearing.