Purdue Pharma L.P.; Withdrawal of Approval of a New Drug Application for Oxycontin, 48177 [2013-18694]
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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withdrawn and has waived its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
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and Use Certification
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National Institutes of Health, has
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48177
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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]
-----------------------------------------------------------------------
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
