Determination That PARAFLEX (Chlorzoxazone) Tablets, 250 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 63228 [2013-24781]
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63228
Federal Register / Vol. 78, No. 205 / Wednesday, October 23, 2013 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–P–0671]
Determination That PARAFLEX
(Chlorzoxazone) Tablets, 250
Milligrams, Was Not Withdrawn From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) has determined
that PARAFLEX (Chlorzoxazone)
Tablets, 250 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withdrawn from sale for reasons of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 PARAFLEX
(Chlorzoxazone) Tablets, 250 mg, if all
other legal and regulatory requirements
are met.
FOR FURTHER INFORMATION CONTACT:
Kathy Schreier, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6252,
Silver Spring, MD 20993–0002, 301–
796–3432.
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
emcdonald on DSK67QTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
18:13 Oct 22, 2013
Jkt 232001
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was withdrawn from sale for reasons of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.
PARAFLEX (Chlorzoxazone) Tablets,
250 mg, is the subject of NDA 11–300,
held by Ortho McNeil Pharm, and was
initially approved on December 12,
1958. PARAFLEX is indicated as an
adjunct to rest, physical therapy, and
other measures for the relief of
discomfort associated with acute,
painful musculoskeletal conditions.
In letters dated April 11, 1997, and
April 22, 1997, a former NDA holder,
The R.W. Johnson Pharmaceutical
Research Institute, notified FDA that
PARAFLEX (Chlorzoxazone) Tablets,
250 mg, had been discontinued and
requested withdrawal of NDA 11–300,
and FDA moved the drug product to the
‘‘Discontinued Drug Product List’’
section of the Orange Book. In the
Federal Register of September 25, 1997
(62 FR 50387), FDA announced that it
was withdrawing approval of NDA 11–
300, effective September 25, 1997.
Lachman Consultant Services, Inc.,
submitted a citizen petition dated June
4, 2013 (Docket No. FDA–2013–P–
0671), under 21 CFR 10.30, requesting
that the Agency determine whether
PARAFLEX (Chlorzoxazone) Tablets,
250 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
§ 314.161 that PARAFLEX
(Chlorzoxazone) Tablets, 250 mg, was
not withdrawn for reasons of safety or
effectiveness. The petitioner has
identified no data or other information
suggesting that PARAFLEX
(Chlorzoxazone) Tablets, 250 mg, was
withdrawn for reasons of safety or
effectiveness. We have carefully
reviewed our files for records
concerning the withdrawal of
PARAFLEX (Chlorzoxazone) Tablets,
250 mg, from sale. We have also
independently evaluated relevant
literature and data for possible
postmarketing adverse events. We have
found no information that would
indicate that this product was
PO 00000
Frm 00071
Fmt 4703
Sfmt 4703
withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will
continue to list PARAFLEX
(Chlorzoxazone) Tablets, 250 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 PARAFLEX (Chlorzoxazone) Tablets,
250 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: October 3, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–24781 Filed 10–22–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–P–0503]
Determination That Potassium Citrate,
10 Milliequivalents/Packet and 20
Milliequivalents/Packet, 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) has determined
that Potassium Citrate, 10
milliequivalents/packet (mEq/packet)
and 20 mEq/packet, was not withdrawn
from sale for reasons of safety or
effectiveness. This determination will
allow FDA to approve abbreviated new
drug applications (ANDAs) for
Potassium Citrate, 10 mEq/packet and
20 mEq/packet, if all other legal and
regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT:
Linda Jong, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, rm. 6224, Silver Spring,
MD 20993–0002, 301–796–3977.
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
SUMMARY:
E:\FR\FM\23OCN1.SGM
23OCN1
]]>Agencies
[Federal Register Volume 78, Number 205 (Wednesday, October 23, 2013)]
[Notices]
[Page 63228]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-24781]
[[Page 63228]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-P-0671]
Determination That PARAFLEX (Chlorzoxazone) Tablets, 250
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) has determined that
PARAFLEX (Chlorzoxazone) Tablets, 250 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 PARAFLEX (Chlorzoxazone) Tablets, 250 mg, if
all other legal and regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: Kathy Schreier, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6252, Silver Spring, MD 20993-0002, 301-
796-3432.
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.
PARAFLEX (Chlorzoxazone) Tablets, 250 mg, is the subject of NDA 11-
300, held by Ortho McNeil Pharm, and was initially approved on December
12, 1958. PARAFLEX is indicated as an adjunct to rest, physical
therapy, and other measures for the relief of discomfort associated
with acute, painful musculoskeletal conditions.
In letters dated April 11, 1997, and April 22, 1997, a former NDA
holder, The R.W. Johnson Pharmaceutical Research Institute, notified
FDA that PARAFLEX (Chlorzoxazone) Tablets, 250 mg, had been
discontinued and requested withdrawal of NDA 11-300, and FDA moved the
drug product to the ``Discontinued Drug Product List'' section of the
Orange Book. In the Federal Register of September 25, 1997 (62 FR
50387), FDA announced that it was withdrawing approval of NDA 11-300,
effective September 25, 1997.
Lachman Consultant Services, Inc., submitted a citizen petition
dated June 4, 2013 (Docket No. FDA-2013-P-0671), under 21 CFR 10.30,
requesting that the Agency determine whether PARAFLEX (Chlorzoxazone)
Tablets, 250 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 PARAFLEX (Chlorzoxazone) Tablets, 250 mg, was
not withdrawn for reasons of safety or effectiveness. The petitioner
has identified no data or other information suggesting that PARAFLEX
(Chlorzoxazone) Tablets, 250 mg, was withdrawn for reasons of safety or
effectiveness. We have carefully reviewed our files for records
concerning the withdrawal of PARAFLEX (Chlorzoxazone) Tablets, 250 mg,
from sale. We have also independently evaluated relevant literature and
data for possible postmarketing adverse events. We have found no
information that would indicate that this product was withdrawn from
sale for reasons of safety or effectiveness.
Accordingly, the Agency will continue to list PARAFLEX
(Chlorzoxazone) Tablets, 250 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 PARAFLEX (Chlorzoxazone) Tablets,
250 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: October 3, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-24781 Filed 10-22-13; 8:45 am]
BILLING CODE 4160-01-P
