[Federal Register Volume 85, Number 247 (Wednesday, December 23, 2020)]
[Notices]
[Pages 83972-83973]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-28283]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-2267]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: 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requested that the approval of this application be withdrawn and has 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.

DATES: Withdrawal of approval is applicable December 23, 2020.

FOR FURTHER INFORMATION CONTACT: Kimberly Lehrfeld, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6226, Silver Spring, MD 20993-0002, 301-
796-3137.

SUPPLEMENTARY INFORMATION: On June 22, 2006, FDA approved NDA 021610 
for OPANA ER (oxymorphone hydrochloride). 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. 
Over the course of 2011 and 2012, Endo removed the original formulation 
from the market.
    Reformulated OPANA ER was intended by the sponsor to be resistant 
to physical and chemical manipulation for abuse by snorting or 
injecting. Although the reformulated product met the regulatory 
standards for approval, FDA determined that the data did not show that 
product could be expected to

[[Page 83973]]

meaningfully reduce abuse and declined the company's request to include 
labeling describing potentially abuse-deterrent properties for OPANA 
ER.
    Based 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. 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). 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 https://www.fda.gov/news-events/press-announcements/fda-requests-removal-opana-er-risks-related-abuse). 
On July 6, 2017, Endo announced it would voluntarily remove 
reformulated OPANA ER from the market.
    On October 3, 2017, Endo requested withdrawal of NDA 201655 for 
reformulated OPANA ER under Sec.  314.150(d) (21 CFR 314.150(d)) and 
waived its opportunity for a hearing. 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 
Sec.  314.150(d). Distribution of reformulated OPANA ER into interstate 
commerce without an approved application is illegal and subject to 
regulatory action (see sections 505(a) and 301(d) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355(a) and 331(d)).

    Dated: December 16, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-28283 Filed 12-22-20; 8:45 am]
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