Determination That SKELAXIN (Metaxalone) Tablets, 400 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 19102 [2014-07659]
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19102
Federal Register / Vol. 79, No. 66 / Monday, April 7, 2014 / Notices
merit an FDA investigation. (See H.
Rept. 857, part 1, 98th Cong., 2d sess.,
pp. 41–42, 1984.) Petitions should be in
the format specified in 21 CFR 10.30.
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) electronic or written
comments and written or electronic
petitions. It is only necessary to send
one set of comments. Identify comments
with the docket number found in
brackets in the heading of this
document. If you submit a written
petition, two copies are required. A
petition submitted electronically must
be submitted to https://
www.regulations.gov, Docket No. FDA–
2013–S–0610. Comments and petitions
that have not been made publicly
available on https://www.regulations.gov
may be viewed in the Division of
Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
Dated: March 27, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–07657 Filed 4–4–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–P–1199]
Determination That SKELAXIN
(Metaxalone) Tablets, 400 Milligrams,
Was Not Withdrawn From Sale for
Reasons of Safety or Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined that SKELAXIN
(metaxalone) Tablets, 400 milligrams
(mg), was not withdrawn from sale for
reasons of safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for SKELAXIN
(metaxalone) Tablets, 400 mg, if all
other legal and regulatory requirements
are met.
FOR FURTHER INFORMATION CONTACT:
Na’Im R. Moses, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6226,
Silver Spring, MD 20993–0002, 240–
402–3990.
SUPPLEMENTARY INFORMATION: In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
17:49 Apr 04, 2014
Jkt 232001
(the 1984 amendments), which
authorized the approval of duplicate
versions of drug products under an
ANDA procedure. ANDA applicants
must, with certain exceptions, show that
the drug for which they are seeking
approval contains the same active
ingredient in the same strength and
dosage form as the ‘‘listed drug,’’ which
is a version of the drug that was
previously approved. ANDA applicants
do not have to repeat the extensive
clinical testing otherwise necessary to
gain approval of a new drug application
(NDA).
The 1984 amendments include what
is now section 505(j)(7) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(7)), which requires FDA to
publish a list of all approved drugs.
FDA publishes this list as part of the
‘‘Approved Drug Products With
Therapeutic Equivalence Evaluations,’’
which is known generally as the
‘‘Orange Book.’’ Under FDA regulations,
drugs are removed from the list if the
Agency withdraws or suspends
approval of the drug’s NDA or ANDA
for reasons of safety or effectiveness or
if FDA determines that the listed drug
was withdrawn from sale for reasons of
safety or effectiveness (21 CFR 314.162).
A person may petition the Agency to
determine, or the Agency may
determine on its own initiative, whether
a listed drug was withdrawn from sale
for reasons of safety or effectiveness.
This determination may be made at any
time after the drug has been withdrawn
from sale, but must be made prior to
approving an ANDA that refers to the
listed drug (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
SKELAXIN (metaxalone) Tablets, 400
mg, is the subject of NDA 13–217, held
by King Pharmaceuticals, Inc., and
initially approved on August 13, 1962.
SKELAXIN (metaxalone) is indicated as
an adjunct to rest, physical therapy, and
other measures for the relief of
discomforts associated with acute,
painful musculoskeletal conditions.
The 400-mg dosage strength is
currently listed in the ‘‘Discontinued
Drug Product List’’ section of the Orange
Book. The applicant continues to
manufacture and distribute an 800-mg
strength tablet of this drug product.
CorePharma, LLC, submitted a citizen
petition dated September 19, 2013
(Docket No. FDA–2013–P–1199), under
21 CFR 10.30, requesting that the
Agency determine whether SKELAXIN
(metaxalone) Tablets, 400 mg, was
withdrawn from sale for reasons of
safety or effectiveness.
After considering the citizen petition
and reviewing Agency records, and
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
based on the information we have at this
time, FDA has determined under
§ 314.161 that SKELAXIN (metaxalone)
Tablets, 400 mg, was not withdrawn for
reasons of safety or effectiveness. The
petitioner has identified no data or other
information suggesting that SKELAXIN
(metaxalone) Tablets, 400 mg, was
withdrawn for reasons of safety or
effectiveness. We have carefully
reviewed our files for records
concerning the withdrawal of
SKELAXIN (metaxalone) Tablets, 400
mg, from sale. We have also
independently evaluated relevant
literature and data for possible
postmarketing adverse events. We have
reviewed the available evidence and
determined that the product was not
withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will
continue to list SKELAXIN (metaxalone)
Tablets, 400 mg, in the ‘‘Discontinued
Drug Product List’’ section of the Orange
Book. The ‘‘Discontinued Drug Product
List’’ delineates, among other items,
drug products that have been
discontinued from marketing for reasons
other than safety or effectiveness.
ANDAs that refer to SKELAXIN
(metaxalone) Tablets, 400 mg, may be
approved by the Agency as long as they
meet all other legal and regulatory
requirements for the approval of
ANDAs. If FDA determines that labeling
for this drug product should be revised
to meet current standards, the Agency
will advise ANDA applicants to submit
such labeling.
Dated: April 1, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–07659 Filed 4–4–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Aging; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
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provisions set forth in sections
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as amended. The grant applications and
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confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
E:\FR\FM\07APN1.SGM
07APN1
]]>Agencies
[Federal Register Volume 79, Number 66 (Monday, April 7, 2014)]
[Notices]
[Page 19102]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-07659]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-P-1199]
Determination That SKELAXIN (Metaxalone) Tablets, 400 Milligrams,
Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined that SKELAXIN (metaxalone) Tablets, 400 milligrams (mg), was
not withdrawn from sale for reasons of safety or effectiveness. This
determination will allow FDA to approve abbreviated new drug
applications (ANDAs) for SKELAXIN (metaxalone) Tablets, 400 mg, if all
other legal and regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: Na'Im R. Moses, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6226, Silver Spring, MD 20993-0002, 240-
402-3990.
SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products under an ANDA procedure. ANDA applicants
must, with certain exceptions, show that the drug for which they are
seeking approval contains the same active ingredient in the same
strength and dosage form as the ``listed drug,'' which is a version of
the drug that was previously approved. ANDA applicants do not have to
repeat the extensive clinical testing otherwise necessary to gain
approval of a new drug application (NDA).
The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which
requires FDA to publish a list of all approved drugs. FDA publishes
this list as part of the ``Approved Drug Products With Therapeutic
Equivalence Evaluations,'' which is known generally as the ``Orange
Book.'' Under FDA regulations, drugs are removed from the list if the
Agency withdraws or suspends approval of the drug's NDA or ANDA for
reasons of safety or effectiveness or if FDA determines that the listed
drug was withdrawn from sale for reasons of safety or effectiveness (21
CFR 314.162).
A person may petition the Agency to determine, or the Agency may
determine on its own initiative, whether a listed drug was withdrawn
from sale for reasons of safety or effectiveness. This determination
may be made at any time after the drug has been withdrawn from sale,
but must be made prior to approving an ANDA that refers to the listed
drug (Sec. 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that
does not refer to a listed drug.
SKELAXIN (metaxalone) Tablets, 400 mg, is the subject of NDA 13-
217, held by King Pharmaceuticals, Inc., and initially approved on
August 13, 1962. SKELAXIN (metaxalone) is indicated as an adjunct to
rest, physical therapy, and other measures for the relief of
discomforts associated with acute, painful musculoskeletal conditions.
The 400-mg dosage strength is currently listed in the
``Discontinued Drug Product List'' section of the Orange Book. The
applicant continues to manufacture and distribute an 800-mg strength
tablet of this drug product.
CorePharma, LLC, submitted a citizen petition dated September 19,
2013 (Docket No. FDA-2013-P-1199), under 21 CFR 10.30, requesting that
the Agency determine whether SKELAXIN (metaxalone) Tablets, 400 mg, was
withdrawn from sale for reasons of safety or effectiveness.
After considering the citizen petition and reviewing Agency
records, and based on the information we have at this time, FDA has
determined under Sec. 314.161 that SKELAXIN (metaxalone) Tablets, 400
mg, was not withdrawn for reasons of safety or effectiveness. The
petitioner has identified no data or other information suggesting that
SKELAXIN (metaxalone) Tablets, 400 mg, was withdrawn for reasons of
safety or effectiveness. We have carefully reviewed our files for
records concerning the withdrawal of SKELAXIN (metaxalone) Tablets, 400
mg, from sale. We have also independently evaluated relevant literature
and data for possible postmarketing adverse events. We have reviewed
the available evidence and determined that the product was not
withdrawn from sale for reasons of safety or effectiveness.
Accordingly, the Agency will continue to list SKELAXIN (metaxalone)
Tablets, 400 mg, in the ``Discontinued Drug Product List'' section of
the Orange Book. The ``Discontinued Drug Product List'' delineates,
among other items, drug products that have been discontinued from
marketing for reasons other than safety or effectiveness. ANDAs that
refer to SKELAXIN (metaxalone) Tablets, 400 mg, may be approved by the
Agency as long as they meet all other legal and regulatory requirements
for the approval of ANDAs. If FDA determines that labeling for this
drug product should be revised to meet current standards, the Agency
will advise ANDA applicants to submit such labeling.
Dated: April 1, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-07659 Filed 4-4-14; 8:45 am]
BILLING CODE 4160-01-P
