American Regent, Inc., et al.; Withdrawal of Approval of Eight Abbreviated New Drug Applications, 72082-72083 [2023-23064]
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Federal Register / Vol. 88, No. 201 / Thursday, October 19, 2023 / Notices
respect to certain device types subject to
special controls, and removing use of
the term ‘‘claims.’’
This guidance is being implemented
without prior public comment because
FDA has determined that prior public
participation for this guidance is not
feasible or appropriate (see section
701(h)(1)(C) of the FD&C Act (21 U.S.C.
371(h)(1)(C)) and § 10.115(g)(2) (21 CFR
10.115(g)(2)). FDA has determined that
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burdensome policy that is consistent
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will consider all comments received and
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practices regulation (§ 10.115). The
guidance represents the current thinking
II. Electronic Access
Persons interested in obtaining a copy
of the guidance may do so by
downloading an electronic copy from
the internet. A search capability for all
Center for Devices and Radiological
Health guidance documents is available
at https://www.fda.gov/medical-devices/
device-advice-comprehensiveregulatory-assistance/guidancedocuments-medical-devices-andradiation-emitting-products. This
guidance document is also available at
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search-fda-guidance-documents.
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Devices Used to Support Patient
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receive an electronic copy of the
document. Please use the document
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title to identify the guidance you are
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III. Paperwork Reduction Act of 1995
While this guidance contains no new
collection of information, it does refer to
previously approved FDA collections of
information. The previously approved
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3521). The collections of information in
the following FDA regulations,
guidance, and forms have been
approved by OMB as listed in the
following table:
OMB control
No.
21 CFR Part
Topic
807, subpart E ............................................................................
800, 801, and 809 ......................................................................
Premarket Notification ................................................................
Medical Device Labeling Regulations ........................................
Dated: October 16, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
ACTION:
The Food and Drug
Administration (FDA or the Agency) is
withdrawing approval of eight
abbreviated new drug applications
(ANDAs) from multiple applicants. The
applicants notified the Agency in
writing that the drug products were no
longer marketed and requested that the
approval of the applications be
withdrawn.
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–4414]
Approval is withdrawn as of
November 20, 2023.
FOR FURTHER INFORMATION CONTACT:
Martha Nguyen, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
DATES:
American Regent, Inc., et al.;
Withdrawal of Approval of Eight
Abbreviated New Drug Applications
AGENCY:
Notice.
SUMMARY:
[FR Doc. 2023–23110 Filed 10–18–23; 8:45 am]
Food and Drug Administration,
HHS.
0910–0120
0910–0485
Hampshire Ave., Bldg. 75, Rm. 1676,
Silver Spring, MD 20993–0002, 240–
402–6980, Martha.Nguyen@fda.hhs.gov.
The
applicants listed in the table have
informed FDA that these drug products
are no longer marketed and have
requested that FDA withdraw approval
of the applications under the process
described in § 314.150(c) (21 CFR
314.150(c)). The applicants have also,
by their requests, waived the
opportunity for a hearing. Withdrawal
of approval of an application or
abbreviated application under
§ 314.150(c) is without prejudice to
refiling.
SUPPLEMENTARY INFORMATION:
Application No.
Drug
Applicant
ANDA 040515 ....................................................
Promethazine Hydrochloride Injectable, 25
milligrams (mg)/milliliter (mL).
Sulfacetamide Sodium Solution/Drops, 10%
and 30%.
Riluzole Tablet, 50 mg .....................................
American Regent, Inc., 5 Ramsey Rd., Shirley, NY 11967.
Allergan Sales, LLC, 2525 Dupont Dr., Irvine,
CA 92612.
Apotex Corp., U.S. Agent for Apotex Inc.,
2400 North Commerce Parkway, Suite 400,
Weston, FL 33326.
Lachman Consultant Services, Inc., U.S.
Agent for Aspen Global Inc., 1600 Stewart
Ave., Suite 604, Westbury, NY 11590.
Apotex Corp., U.S. Agent for Apotex Inc.
ANDA 080028 ....................................................
ANDA 091300 ....................................................
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of FDA on ‘‘Enforcement Policy for NonInvasive Remote Monitoring Devices
Used to Support Patient Monitoring.’’ It
does not establish any rights for any
person and is not binding on FDA or the
public. You can use an alternative
approach if it satisfies the requirements
of the applicable statutes and
regulations.
ANDA 200271 ....................................................
Hydroxyprogesterone
Caproate
1,250 mg/5 mL (250 mg/mL).
ANDA 201570 ....................................................
Abacavir Sulfate Tablet, Equivalent to (EQ)
300 mg base.
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Federal Register / Vol. 88, No. 201 / Thursday, October 19, 2023 / Notices
Application No.
Drug
Applicant
ANDA 202784 ....................................................
Esomeprazole Magnesium Capsule, Delayed
Release Pellets, EQ 20 mg base and EQ 40
mg base.
Choline C–11 Injectable, 4–33.1 millicurie/mL
Hetero USA, Inc., U.S. Agent for Hetero Labs
Ltd., Unit-III, 1035 Centennial Ave.,
Piscataway, NJ 08854.
Washington University School of Medicine,
510 South Kingshighway Blvd., St. Louis,
MO 63110.
Hetero USA, Inc., U.S. Agent for Hetero Labs
Ltd.
ANDA 208413 ....................................................
ANDA 208939 ....................................................
Esomeprazole Magnesium Capsule, Delayed
Release, EQ 20 mg base.
Therefore, approval of the
applications listed in the table, and all
amendments and supplements thereto,
is hereby withdrawn as of November 20,
2023. Approval of each entire
application is withdrawn, including any
strengths and dosage forms
inadvertently missing from the table.
Introduction or delivery for introduction
into interstate commerce of products
listed in the table without an approved
new drug application or abbreviated
new drug application violates sections
505(a) and 301(d) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C.
355(a) and 331(d)). Drug products that
are listed in the table that are in
inventory on November 20, 2023 may
continue to be dispensed until the
inventories have been depleted or the
drug products have reached their
expiration dates or otherwise become
violative, whichever occurs first.
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995
(PRA).
DATES: Submit written comments
(including recommendations) on the
collection of information by November
20, 2023.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
collection is 0910–0497. Also include
the FDA docket number found in
brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
JonnaLynn Capezzuto, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 10A–12M, 11601 Landsdown St.,
North Bethesda, MD 20852, 301–796–
3794, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Dated: October 13, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–23064 Filed 10–18–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–1005]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Focus Groups and
Interviews as Used by the Food and
Drug Administration
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
SUMMARY:
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72083
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Focus Groups and Interviews as Used
by the Food and Drug Administration
OMB Control No. 0910–0497—Extension
FDA conducts focus groups and indepth individual interviews on a variety
of topics involving FDA-regulated
products, including drugs, biologics,
devices, food, tobacco products, and
veterinary medicine.
Focus groups are an important role in
gathering information because they
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allow for a better understanding of
consumers’ attitudes, beliefs,
motivations, and feelings than do
quantitative studies and encourages
interaction between participants.
Individual interviews allow for a
more comprehensive, in-depth
information exchange where more
insights are likely to be collected.
Both focus groups and in-depth
individual interviews serve the
narrowly defined need for direct and
informal opinion on a specific topic
and, as a qualitative research tool, have
three major purposes:
• To obtain consumer information
that is useful for developing variables
and measures for quantitative studies,
• To better understand consumers’
attitudes and emotions in response to
topics and concepts, and
• To further explore findings
obtained from quantitative studies.
FDA will use findings to test and
refine ideas but will generally conduct
further research before making
important decisions, such as adopting
new policies and allocating or
redirecting significant resources to
support these policies.
Respondents to this collection of
information will include members of the
general public, healthcare professionals,
the industry, and other stakeholders
who are related to a product under
FDA’s jurisdiction. Inclusion and
exclusion criteria will vary depending
on the research topic.
In the Federal Register of April 11,
2023 (88 FR 21680), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. Three comments were
received, two in support of the
information collection, and one that did
not address the elements of the PRA.
FDA estimates the burden of this
collection of information as follows:
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]]>Agencies
[Federal Register Volume 88, Number 201 (Thursday, October 19, 2023)]
[Notices]
[Pages 72082-72083]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-23064]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-4414]
American Regent, Inc., et al.; Withdrawal of Approval of Eight
Abbreviated New Drug Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or the Agency) is
withdrawing approval of eight abbreviated new drug applications (ANDAs)
from multiple applicants. The applicants notified the Agency in writing
that the drug products were no longer marketed and requested that the
approval of the applications be withdrawn.
DATES: Approval is withdrawn as of November 20, 2023.
FOR FURTHER INFORMATION CONTACT: Martha Nguyen, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1676, Silver Spring, MD 20993-0002, 240-
402-6980, [email protected].
SUPPLEMENTARY INFORMATION: The applicants listed in the table have
informed FDA that these drug products are no longer marketed and have
requested that FDA withdraw approval of the applications under the
process described in Sec. 314.150(c) (21 CFR 314.150(c)). The
applicants have also, by their requests, waived the opportunity for a
hearing. Withdrawal of approval of an application or abbreviated
application under Sec. 314.150(c) is without prejudice to refiling.
------------------------------------------------------------------------
Application No. Drug Applicant
------------------------------------------------------------------------
ANDA 040515..................... Promethazine American Regent,
Hydrochloride Inc., 5 Ramsey
Injectable, 25 Rd., Shirley, NY
milligrams (mg)/ 11967.
milliliter (mL).
ANDA 080028..................... Sulfacetamide Allergan Sales,
Sodium Solution/ LLC, 2525 Dupont
Drops, 10% and Dr., Irvine, CA
30%. 92612.
ANDA 091300..................... Riluzole Tablet, Apotex Corp., U.S.
50 mg. Agent for Apotex
Inc., 2400 North
Commerce Parkway,
Suite 400,
Weston, FL 33326.
ANDA 200271..................... Hydroxyprogesteron Lachman Consultant
e Caproate Services, Inc.,
Solution, 1,250 U.S. Agent for
mg/5 mL (250 mg/ Aspen Global
mL). Inc., 1600
Stewart Ave.,
Suite 604,
Westbury, NY
11590.
ANDA 201570..................... Abacavir Sulfate Apotex Corp., U.S.
Tablet, Agent for Apotex
Equivalent to Inc.
(EQ) 300 mg base.
[[Page 72083]]
ANDA 202784..................... Esomeprazole Hetero USA, Inc.,
Magnesium U.S. Agent for
Capsule, Delayed Hetero Labs Ltd.,
Release Pellets, Unit-III, 1035
EQ 20 mg base and Centennial Ave.,
EQ 40 mg base. Piscataway, NJ
08854.
ANDA 208413..................... Choline C-11 Washington
Injectable, 4- University School
33.1 millicurie/ of Medicine, 510
mL. South
Kingshighway
Blvd., St. Louis,
MO 63110.
ANDA 208939..................... Esomeprazole Hetero USA, Inc.,
Magnesium U.S. Agent for
Capsule, Delayed Hetero Labs Ltd.
Release, EQ 20 mg
base.
------------------------------------------------------------------------
Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of
November 20, 2023. Approval of each entire application is withdrawn,
including any strengths and dosage forms inadvertently missing from the
table. Introduction or delivery for introduction into interstate
commerce of products listed in the table without an approved new drug
application or abbreviated new drug application violates sections
505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355(a) and 331(d)). Drug products that are listed in the table
that are in inventory on November 20, 2023 may continue to be dispensed
until the inventories have been depleted or the drug products have
reached their expiration dates or otherwise become violative, whichever
occurs first.
Dated: October 13, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-23064 Filed 10-18-23; 8:45 am]
BILLING CODE 4164-01-P
