Purdue Pharma L.P.; Withdrawal of Approval of a New Drug Application for Oxycontin, 48177 [2013-18694]

Download as PDF Federal Register / Vol. 78, No. 152 / Wednesday, August 7, 2013 / Notices Dated: August 2, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–19051 Filed 8–6–13; 8:45 am] BILLING CODE 4160–01–P 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. 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 Purdue has voluntarily requested that approval of this application (NDA 20–553) be withdrawn and has waived its opportunity for a hearing.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) ExtendedRelease 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) ExtendedRelease 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 mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 17:03 Aug 06, 2013 Jkt 229001 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Submission for OMB Review; 30-day Comment Request: National Institute of Mental Health Data Access Request and Use Certification Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute of Mental Health (NIMH), the National Institutes of Health, has submitted to the Office of Management SUMMARY: PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 48177 and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on May 28, 2013, Volume 78, Number 102, Pages 31947–31948 and allowed 60days for public comment. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institute of Mental Health (NIMH), National Institutes of Health, may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by fax to 202–395–6974, Attention: NIH Desk Officer. DATES: Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication. FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data collection plans and instruments, or request more information on the proposed project, contact: Keisha Shropshire, NIMH Project Clearance Liaison, Science Policy and Evaluation Branch, OSPPC, NIMH, NIH, Neuroscience Center, 6001 Executive Boulevard, MSC 9667, Rockville Pike, Bethesda, MD 20892, or call 301–443–4335 or email your request, including your address to: kshropsh@mail.nih.gov. Formal requests for additional plans and instruments must be requested in writing. Proposed Collection: The National Institute of Mental Health Data Access Request and Use Certification (previously National Database for Autism Research Data Access Request), 0925–0667, Revision, Expiration Date: 01/31/2016; National Institute of Mental Health (NIMH), National Institutes of Health (NIH). Need and Use of Information Collection: NIMH recently received OMB approval for use of the National Database for Autism Research (NDAR) Data Use Certification (DUC) Form. NIMH is interested in renaming this form the ‘‘NIMH Data Access Request and Use Certification (DUC) Form’’ and using it to meet the unique data access E:\FR\FM\07AUN1.SGM 07AUN1

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


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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.

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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