![]() ![]() For the reasons discussed above, and pursuant to the applicant's request, approval of NDA 201655 for reformulated OPANA ER (oxymorphone hydrochloride) extended-release tablets, and all amendments and supplements thereto, is withdrawn under § 314.150(d). On October 3, 2017, Endo requested withdrawal of NDA 201655 for reformulated OPANA ER under § 314.150(d) ( 21 CFR 314.150(d)) and waived its opportunity for a hearing. On July 6, 2017, Endo announced it would voluntarily remove reformulated OPANA ER from the market. On June 8, 2017, FDA requested that Endo remove reformulated OPANA ER from the market based on its concern that the benefits of the drug may no longer outweigh its risks due to the public health consequences of abuse (see news-events/press-announcements/fda-requests-removal-opana-er-risks-related-abuse). Injection abuse of reformulated OPANA ER has been associated with a serious outbreak of HIV and hepatitis C, as well as cases of a serious blood disorder (thrombotic microangiopathy). Although the reformulated product met the regulatory standards for approval, FDA determined that the data did not show that product could be expected to Start Printed 73meaningfully reduce abuse and declined the company's request to include labeling describing potentially abuse-deterrent properties for OPANA ER.īased on postmarketing data, FDA later observed that there was a significant shift in the route of abuse from nasal to injection following the product's reformulation. Reformulated OPANA ER was intended by the sponsor to be resistant to physical and chemical manipulation for abuse by snorting or injecting. ![]() ![]() Over the course of 20, Endo removed the original formulation from the market. On December 9, 2011, FDA approved a new formulation of OPANA ER (oxymorphone hydrochloride) tablets, 5 milligrams (mg), 7.5 mg, 10 mg, 15 mg, 20 mg, 30 mg, and 40 mg, under NDA 201655 (“reformulated OPANA ER”) for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. On June 22, 2006, FDA approved NDA 021610 for OPANA ER (oxymorphone hydrochloride). End Further Info End Preamble Start Supplemental Information SUPPLEMENTARY INFORMATION: Kimberly Lehrfeld, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. Start Further Info FOR FURTHER INFORMATION CONTACT: Withdrawal of approval is applicable December 23, 2020. Endo requested that the approval of this application be withdrawn and has waived its opportunity for a hearing. 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). Provide legal notice to the public or judicial notice to the courts.įood and Drug Administration, HHS. Rendition of the daily Federal Register on does not Until the ACFR grants it official status, the XML Legal research should verify their results against an official edition of The official SGML-based PDF version on, those relying on it for The material on is accurately displayed, consistent with While every effort has been made to ensure that Regulatory information on with the objective ofĮstablishing the XML-based Federal Register as an ACFR-sanctioned The OFR/GPO partnership is committed to presenting accurate and reliable Register (ACFR) issues a regulation granting it official legal status.įor complete information about, and access to, our official publications Informational resource until the Administrative Committee of the Federal This prototype edition of theĭaily Federal Register on will remain an unofficial Each document posted on the site includes a link to theĬorresponding official PDF file on. The documents posted on this site are XML renditions of published Federal Register, and does not replace the official print version or the official It is not an official legal edition of the Federal This site displays a prototype of a “Web 2.0” version of the dailyįederal Register. ![]()
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