Determination That LOTENSIN (Benazepril Hydrochloride) Tablets, 5 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 6748 [2023-02101]
Download as PDF
<![CDATA[
6748
Federal Register / Vol. 88, No. 21 / Wednesday, February 1, 2023 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–P–1785]
Determination That LOTENSIN
(Benazepril Hydrochloride) Tablets, 5
Milligrams, Were Not Withdrawn From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, Agency, or we)
has determined that LOTENSIN
(benazepril hydrochloride) tablets, 5
milligrams (mg), were not withdrawn
from sale for reasons of safety or
effectiveness. This determination means
that FDA will not begin procedures to
withdraw approval 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.
SUMMARY:
lotter on DSK11XQN23PROD with NOTICES1
FOR FURTHER INFORMATION CONTACT:
Nisha Shah, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 6222, Silver Spring,
MD 20993–0002, 301–796–4455,
Nisha.Shah@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Section
505(j) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C.
355(j)) allows the submission of an
ANDA to market a generic version of a
previously approved drug product. To
obtain approval, the ANDA applicant
must show, among other things, that the
generic drug product: (1) has the same
active ingredient(s), dosage form, route
of administration, strength, conditions
of use, and (with certain exceptions)
labeling as the listed drug, which is a
version of the drug that was previously
approved and (2) is bioequivalent to the
listed drug. ANDA applicants do not
have to repeat the extensive clinical
testing otherwise necessary to gain
approval of a new drug application
(NDA).
Section 505(j)(7) of the FD&C Act
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
VerDate Sep<11>2014
21:04 Jan 31, 2023
Jkt 259001
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.
LOTENSIN (benazepril
hydrochloride) tablets, 5 mg, are the
subject of NDA 019851, held by Validus
Pharmaceuticals LLC, and initially
approved on June 25, 1991. LOTENSIN
is indicated for the treatment of
hypertension to lower blood pressure.
LOTENSIN (benazepril
hydrochloride) tablets, 5 mg, are
currently listed in the ‘‘Discontinued
Drug Product List’’ section of the Orange
Book.
Aurobindo Pharma Ltd. submitted a
citizen petition dated August 3, 2022
(Docket No. FDA–2022–P–1785), under
21 CFR 10.30, requesting that the
Agency determine whether LOTENSIN
(benazepril hydrochloride) tablets, 5 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 LOTENSIN (benazepril
hydrochloride) tablets, 5 mg, were not
withdrawn for reasons of safety or
effectiveness. The petitioner has
identified no data or other information
suggesting that LOTENSIN (benazepril
hydrochloride) tablets, 5 mg, were
withdrawn for reasons of safety or
effectiveness. We have carefully
reviewed our files for records
concerning the withdrawal of
LOTENSIN (benazepril hydrochloride)
tablets, 5 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 LOTENSIN (benazepril
hydrochloride) tablets, 5 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
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
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: January 27, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–02101 Filed 1–31–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–D–2983]
Considerations for the Design and
Conduct of Externally Controlled Trials
for Drug and Biological Products; Draft
Guidance for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled
‘‘Considerations for the Design and
Conduct of Externally Controlled Trials
for Drug and Biological Products.’’ FDA
is issuing this draft guidance as part of
a series of guidance documents under
its Real-World Evidence (RWE) Program
and to satisfy, in part, a mandate under
the Federal Food, Drug, and Cosmetic
Act (FD&C Act) to issue guidance about
the use of RWE in regulatory decisionmaking. This draft guidance includes
recommendations to sponsors and
investigators considering the use of
externally controlled trials to provide
evidence of the safety and effectiveness
of a drug product. The draft guidance
also describes considerations related to
communicating with FDA and ensuring
access by the Agency to data from an
externally controlled trial.
DATES: Submit either electronic or
written comments on the draft guidance
by May 2, 2023 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
SUMMARY:
E:\FR\FM\01FEN1.SGM
01FEN1
]]>Agencies
[Federal Register Volume 88, Number 21 (Wednesday, February 1, 2023)]
[Notices]
[Page 6748]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-02101]
[[Page 6748]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-P-1785]
Determination That LOTENSIN (Benazepril Hydrochloride) Tablets, 5
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, Agency, or we) has
determined that LOTENSIN (benazepril hydrochloride) tablets, 5
milligrams (mg), were not withdrawn from sale for reasons of safety or
effectiveness. This determination means that FDA will not begin
procedures to withdraw approval 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: Nisha Shah, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 6222, Silver Spring, MD 20993-0002, 301-796-4455,
[email protected].
SUPPLEMENTARY INFORMATION: Section 505(j) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)) allows the submission of
an ANDA to market a generic version of a previously approved drug
product. To obtain approval, the ANDA applicant must show, among other
things, that the generic drug product: (1) has the same active
ingredient(s), dosage form, route of administration, strength,
conditions of use, and (with certain exceptions) labeling as the listed
drug, which is a version of the drug that was previously approved and
(2) is bioequivalent to the listed drug. ANDA applicants do not have to
repeat the extensive clinical testing otherwise necessary to gain
approval of a new drug application (NDA).
Section 505(j)(7) of the FD&C Act 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.
LOTENSIN (benazepril hydrochloride) tablets, 5 mg, are the subject
of NDA 019851, held by Validus Pharmaceuticals LLC, and initially
approved on June 25, 1991. LOTENSIN is indicated for the treatment of
hypertension to lower blood pressure.
LOTENSIN (benazepril hydrochloride) tablets, 5 mg, are currently
listed in the ``Discontinued Drug Product List'' section of the Orange
Book.
Aurobindo Pharma Ltd. submitted a citizen petition dated August 3,
2022 (Docket No. FDA-2022-P-1785), under 21 CFR 10.30, requesting that
the Agency determine whether LOTENSIN (benazepril hydrochloride)
tablets, 5 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 LOTENSIN (benazepril hydrochloride) tablets, 5
mg, were not withdrawn for reasons of safety or effectiveness. The
petitioner has identified no data or other information suggesting that
LOTENSIN (benazepril hydrochloride) tablets, 5 mg, were withdrawn for
reasons of safety or effectiveness. We have carefully reviewed our
files for records concerning the withdrawal of LOTENSIN (benazepril
hydrochloride) tablets, 5 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 LOTENSIN (benazepril
hydrochloride) tablets, 5 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. 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: January 27, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-02101 Filed 1-31-23; 8:45 am]
BILLING CODE 4164-01-P
