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SERENTIL (Mesoridazine Besylate) Tablets, 10 Milligrams, 25 Milligrams, 50 Milligrams, and 100 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 17159 [2021-06722]
Download as PDF
<![CDATA[
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Not Withdrawn From Sale for Reasons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mg, were not withdrawn from sale for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
]]>Agencies
[Federal Register Volume 86, Number 61 (Thursday, April 1, 2021)]
[Notices]
[Page 17159]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-06722]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
SUMMARY: 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,
[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.
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 Sec. 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 (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
