[Federal Register Volume 78, Number 152 (Wednesday, August 7, 2013)]
[Notices]
[Page 48177]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-18694]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0883]


Purdue Pharma L.P.; Withdrawal of Approval of a New Drug 
Application for Oxycontin

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of a new drug application (NDA) for OXYCONTIN (oxycodone hydrochloride) 
Extended-Release Tablets, held by Purdue Pharma L.P. (Purdue), One 
Stamford Forum, Stamford, CT 06901-3431. Purdue has voluntarily 
requested that approval of this application (NDA 20-553) be withdrawn 
and has waived its opportunity for a hearing.

DATES: Effective August 7, 2013.

FOR FURTHER INFORMATION CONTACT: Patrick Raulerson, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 6368, Silver Spring, MD 20993-0002, 301-
796-3522.

SUPPLEMENTARY INFORMATION: FDA approved NDA 20-553 for OXYCONTIN 
(oxycodone hydrochloride) Extended-Release Tablets, 10 milligrams (mg), 
15 mg, 20 mg, 30 mg, 40 mg, 60 mg, 80 mg, and 160 mg, (original 
OxyContin), on December 12, 1995. A reformulated version of these 
products, OXYCONTIN (oxycodone hydrochloride) Extended-Release Tablets, 
10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg, and 80 mg (reformulated 
OxyContin), is the subject of NDA 22-272, also held by Purdue and 
initially approved on April 5, 2010. Reformulated OxyContin was 
developed with physicochemical properties that are intended to make the 
tablet more difficult to manipulate for purposes of abuse or misuse. 
Both original and reformulated OxyContin are opioid agonist products. 
Original OxyContin was indicated for the management of moderate to 
severe pain when a continuous, around-the-clock opioid analgesic is 
needed for an extended period of time.
    In correspondence dated August 10, 2010, Purdue notified FDA that 
it had ceased shipment of original OxyContin, and FDA subsequently 
moved original OxyContin to the ``Discontinued Drug Product List'' 
section of the Orange Book. In a letter to FDA dated March 19, 2013, 
Purdue requested that FDA withdraw approval of NDA 20-553 for original 
OxyContin, noting that the original formulation of OxyContin was 
subject to abuse and misuse, and that it was ``not possible to develop 
labeling or REMS provisions that would create a positive risk/benefit 
ratio for the original formulation of OxyContin.'' In that letter, 
Purdue waived its right to a hearing.
    On April 18, 2013, FDA published notice of its determination that 
original OxyContin, NDA 20-553, was withdrawn from sale for reasons of 
safety or effectiveness (78 FR 23273). The notice concluded that 
``[o]riginal OxyContin . . . poses an increased potential for abuse by 
certain routes of administration, when compared to reformulated 
OxyContin. Based on the totality of the data and information available 
to the Agency at this time, FDA concludes that the benefits of original 
OxyContin no longer outweigh its risks.''
    Under section 505(e) of the Federal Food, Drug, and Cosmetic Act 
(the FD&C Act) (21 U.S.C. 355(e)), and under authority delegated by the 
Commissioner to the Director, Center for Drug Evaluation and Research, 
approval of NDA 20-553, and all amendments and supplements thereto, is 
withdrawn (see DATES). Distribution of this product in interstate 
commerce without an approved application is illegal and subject to 
regulatory action (see sections 505(a) and 301(d) of the FD&C Act (21 
U.S.C. 355(a) and 331(d)).

    Dated: July 30, 2013.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 2013-18694 Filed 8-6-13; 8:45 am]
BILLING CODE 4160-01-P