Determination That CUTIVATE (Fluticasone Propionate) Ointment, 0.005 Percent, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 17159-17160 [2021-06721]
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Federal Register / Vol. 86, No. 61 / Thursday, April 1, 2021 / Notices
No. FDA–2013–S–0610. Submit written
petitions (two copies are required) to the
Dockets Management Staff (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD
20852.
Dated: March 26, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–06693 Filed 3–31–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–P–1881]
Determination That SERENTIL
(Mesoridazine Besylate) Tablets, 10
Milligrams, 25 Milligrams, 50
Milligrams, and 100 Milligrams, Were
Not Withdrawn From Sale for Reasons
of Safety or Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, the Agency, or
we) has determined that SERENTIL
(mesoridazine besylate) tablets, 10
milligrams (mg), 25 mg, 50 mg, and 100
mg, were not withdrawn from sale for
reasons of safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for mesoridazine
besylate tablets, 10 mg, 25 mg, 50 mg,
and 100 mg, if all other legal and
regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT:
Ayako Sato, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 6206, Silver Spring,
MD 20993–0002, 240–402–4191,
Ayako.Sato@fda.hhs.gov.
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
jbell on DSKJLSW7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
19:02 Mar 31, 2021
Jkt 253001
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.
SERENTIL (mesoridazine besylate)
tablets, 10 mg, 25 mg, 50 mg, and 100
mg, are the subject of NDA 16774, held
by Norvartis Pharmaceuticals
Corporation, and initially approved on
February 27, 1970. SERENTIL is
indicated for the management of
schizophrenic patients who fail to
respond adequately to treatment with
other antipsychotic drugs.
In a letter dated September 9, 2008,
Novartis Pharmaceuticals Corporation
requested withdrawal of NDA 16774 for
SERENTIL (mesoridazine besylate)
tablets, 10 mg, 25 mg, 50 mg, and 100
mg. In the Federal Register of February
22, 2018 (83 FR 7738), FDA announced
that it was withdrawing approval of
NDA 16774, effective March 26, 2018.
The Weinberg Group submitted a
citizen petition dated September 15,
2020 (Docket No. FDA–2020–P–1881),
under 21 CFR 10.30, requesting that the
Agency determine whether SERENTIL
(mesoridazine besylate) tablets, 10 mg,
25 mg, 50 mg, and 100 mg, were
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 SERENTIL (mesoridazine
besylate) tablets, 10 mg, 25 mg, 50 mg,
and 100 mg, were not withdrawn for
reasons of safety or effectiveness. The
petitioner has identified no data or other
information suggesting that SERENTIL
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
17159
(mesoridazine besylate) tablets, 10 mg,
25 mg, 50 mg, and 100 mg, were
withdrawn for reasons of safety or
effectiveness. We have carefully
reviewed our files for records
concerning the withdrawal of
SERENTIL (mesoridazine besylate)
tablets, 10 mg, 25 mg, 50 mg, and 100
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 this drug product was
not withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will
continue to list SERENTIL
(mesoridazine besylate) tablets, 10 mg,
25 mg, 50 mg, and 100 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 SERENTIL (mesoridazine besylate)
tablets, 10 mg, 25 mg, 50 mg, and 100
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: March 29, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–06722 Filed 3–31–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–N–0289]
Determination That CUTIVATE
(Fluticasone Propionate) Ointment,
0.005 Percent, 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 Agency) has
determined that CUTIVATE (fluticasone
propionate) ointment, 0.005 percent,
was not withdrawn from sale for reasons
of safety or effectiveness. This
determination means that FDA will not
begin procedures to withdraw approval
SUMMARY:
E:\FR\FM\01APN1.SGM
01APN1
jbell on DSKJLSW7X2PROD with NOTICES
17160
Federal Register / Vol. 86, No. 61 / Thursday, April 1, 2021 / Notices
of abbreviated new drug applications
(ANDAs) that refer to this drug product,
and it will allow FDA to continue to
approve ANDAs that refer to the
product as long as they meet relevant
legal and regulatory requirements.
FOR FURTHER INFORMATION CONTACT:
Heather Dorsey, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6220,
Silver Spring, MD 20993–0002, 301–
796–3600, heather.dorsey@fda.hhs.gov.
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 (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
CUTIVATE (fluticasone propionate)
ointment, 0.005 percent, is the subject of
NDA 019957, held by Fougera
Pharmaceuticals, Inc., and initially
approved on December 14, 1990.
CUTIVATE is indicated for the relief of
the inflammatory and pruritic
VerDate Sep<11>2014
19:02 Mar 31, 2021
Jkt 253001
manifestations of corticosteroidresponsive dermatoses in adult patients.
CUTIVATE (fluticasone propionate)
ointment, 0.005 percent, is currently
listed in the ‘‘Discontinued Drug
Product List’’ section of the Orange
Book.
BF Innovation Inc., acting on behalf of
Bright Future Pharmaceutical
Laboratories Limited, submitted a
citizen petition dated November 2, 2020
(Docket No. FDA–2020–P–2146), under
21 CFR 10.30, requesting that the
Agency determine whether CUTIVATE
(fluticasone propionate) ointment, 0.005
percent, 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 CUTIVATE (fluticasone
propionate) ointment, 0.005 percent,
was not withdrawn for reasons of safety
or effectiveness. The petitioner has
identified no data or other information
suggesting that this drug product was
withdrawn for reasons of safety or
effectiveness. We have carefully
reviewed our files for records
concerning the withdrawal of
CUTIVATE (fluticasone propionate)
ointment, 0.005 percent, 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 drug product was
withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will
continue to list CUTIVATE (fluticasone
propionate) ointment, 0.005 percent, 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. FDA will not
begin procedures to withdraw approval
of approved ANDAs that refer to this
drug product. Additional ANDAs for
this drug product may also 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: March 29, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–06721 Filed 3–31–21; 8:45 am]
BILLING CODE 4164–01–P
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2019–E–3183 and FDA–
2019–E–3184]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; TPOXX
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) has
determined the regulatory review period
for TPOXX and is publishing this notice
of that determination as required by
law. FDA has made the determination
because of the submission of
applications to the Director of the U.S.
Patent and Trademark Office (USPTO),
Department of Commerce, for the
extension of a patent which claims that
human drug product.
DATES: Anyone with knowledge that any
of the dates as published (see the
SUPPLEMENTARY INFORMATION section) are
incorrect may submit either electronic
or written comments and ask for a
redetermination by June 1, 2021.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
September 28, 2021. See ‘‘Petitions’’ in
the SUPPLEMENTARY INFORMATION section
for more information.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before June 1, 2021.
The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of June 1, 2021. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
E:\FR\FM\01APN1.SGM
01APN1
]]>Agencies
[Federal Register Volume 86, Number 61 (Thursday, April 1, 2021)]
[Notices]
[Pages 17159-17160]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-06721]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-0289]
Determination That CUTIVATE (Fluticasone Propionate) Ointment,
0.005 Percent, 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 Agency) has
determined that CUTIVATE (fluticasone propionate) ointment, 0.005
percent, was not withdrawn from sale for reasons of safety or
effectiveness. This determination means that FDA will not begin
procedures to withdraw approval
[[Page 17160]]
of abbreviated new drug applications (ANDAs) that refer to this drug
product, and it will allow FDA to continue to approve ANDAs that refer
to the product as long as they meet relevant legal and regulatory
requirements.
FOR FURTHER INFORMATION CONTACT: Heather Dorsey, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6220, Silver Spring, MD 20993-0002, 301-
796-3600, [email protected].
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.
CUTIVATE (fluticasone propionate) ointment, 0.005 percent, is the
subject of NDA 019957, held by Fougera Pharmaceuticals, Inc., and
initially approved on December 14, 1990. CUTIVATE is indicated for the
relief of the inflammatory and pruritic manifestations of
corticosteroid-responsive dermatoses in adult patients. CUTIVATE
(fluticasone propionate) ointment, 0.005 percent, is currently listed
in the ``Discontinued Drug Product List'' section of the Orange Book.
BF Innovation Inc., acting on behalf of Bright Future
Pharmaceutical Laboratories Limited, submitted a citizen petition dated
November 2, 2020 (Docket No. FDA-2020-P-2146), under 21 CFR 10.30,
requesting that the Agency determine whether CUTIVATE (fluticasone
propionate) ointment, 0.005 percent, 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 CUTIVATE (fluticasone propionate) ointment,
0.005 percent, was not withdrawn for reasons of safety or
effectiveness. The petitioner has identified no data or other
information suggesting that this drug product was withdrawn for reasons
of safety or effectiveness. We have carefully reviewed our files for
records concerning the withdrawal of CUTIVATE (fluticasone propionate)
ointment, 0.005 percent, 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 drug product was withdrawn from sale for reasons of safety or
effectiveness.
Accordingly, the Agency will continue to list CUTIVATE (fluticasone
propionate) ointment, 0.005 percent, 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. FDA will not begin procedures to withdraw approval of
approved ANDAs that refer to this drug product. Additional ANDAs for
this drug product may also 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: March 29, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-06721 Filed 3-31-21; 8:45 am]
BILLING CODE 4164-01-P
