Fresenius Kabi USA, LLC, et al.; Withdrawal of Approval of Five Abbreviated New Drug Applications, 11079-11080 [2022-04153]
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Federal Register / Vol. 87, No. 39 / Monday, February 28, 2022 / Notices
management of the patient’s disease. In
addition, FDA committed to meet
certain performance goals under the
sixth authorization of the Prescription
Drug User Fee Act. These goal
commitments were developed in
consultation with patient and consumer
advocates, healthcare professionals, and
other public stakeholders, as part of
negotiations with regulated industry.
Section J.1 of the commitment letter,
‘‘Enhancing the Incorporation of the
Patient’s Voice in Drug Development
and Decision-Making’’ (https://
www.fda.gov/downloads/ForIndustry/
UserFees/PrescriptionDrugUserFee/
UCM511438.pdf), outlines work,
including the development of a series of
guidance documents and associated
public workshops to facilitate the
advancement and use of systematic
approaches to collect and use robust
and meaningful patient and caregiver
input that can more consistently inform
drug development, and, as appropriate,
regulatory decision making.
IV. Electronic Access
Persons with access to the internet
may obtain the guidance at https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, https://
www.fda.gov/regulatory-information/
search-fda-guidance-documents, or
https://www.regulations.gov.
Dated: February 22, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–04152 Filed 2–25–22; 8:45 am]
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11079
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Food and Drug Administration
[Docket No. FDA–2021–N–0002]
[Docket No. FDA–2022–N–0030]
New Animal Drugs; Withdrawal of
Approval of New Animal Drug
Application
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notification of withdrawal.
The Food and Drug
Administration (FDA) is withdrawing
approval of a new animal drug
application (NADA) at the sponsor’s
request because the product is no longer
manufactured or marketed.
DATES: The approval is withdrawn as of
February 28, 2022.
FOR FURTHER INFORMATION CONTACT:
Sujaya Dessai, Center for Veterinary
Medicine (HFV–212), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–402–5761,
sujaya.dessai@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Elanco US
Inc., 2500 Innovation Way, Greenfield,
IN 46140, has requested that FDA
withdraw approval of NADA 093–329
for use of a prolonged-release bolus
containing sulfamethazine in cattle
because the product is no longer
manufactured or marketed.
Therefore, under authority delegated
to the Commissioner of Food and Drugs
and in accordance with § 514.116 Notice
of withdrawal of approval of application
(21 CFR 514.116), notice is given that
approval of NADA 093–329, and all
supplements and amendments thereto,
is hereby withdrawn February 28, 2022.
Elsewhere in this issue of the Federal
Register, FDA is amending the animal
drug regulations to reflect the voluntary
withdrawal of approval of this
application.
SUMMARY:
Dated: February 14, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
Fresenius Kabi USA, LLC, et al.;
Withdrawal of Approval of Five
Abbreviated New Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of five
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.
SUMMARY:
Approval is withdrawn as of
March 30, 2022
DATES:
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, 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 their
opportunity for a hearing. Withdrawal
of approval of an application or
abbreviated application under
§ 314.150(c) is without prejudice to
refiling.
SUPPLEMENTARY INFORMATION:
[FR Doc. 2022–03539 Filed 2–25–22; 8:45 am]
khammond on DSKJM1Z7X2PROD with NOTICES
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Application No.
Drug
Applicant
ANDA 065408 ....
Epirubicin Hydrochloride (HCl) Injection, 150 milligrams (mg)/
75 milliliters (mL) (2 mg/mL), 10 mg/5 mL (2 mg/mL), 50
mg/25 mL (2 mg/mL), and 200 mg/100 mL (2 mg/mL).
Epirubicin HCl Injection, 200 mg/100 mL (2 mg/mL) and 50
mg/25 mL (2 mg/mL).
Idarubicin HCl Injection, 1 mg/mL ............................................
Fludarabine Phosphate for Injection, 50 mg/vial .....................
Gabapentin Capsules, 100 mg, 300 mg, and 400 mg ............
Fresenius Kabi USA, LLC, Three Corporate Dr., Lake Zurich,
IL 60047.
ANDA 065411 ....
ANDA 065440 ....
ANDA 077790 ....
ANDA 091008 ....
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Do.
Do.
Hospira, Inc., 275 North Field Dr., Lake Forest, IL 60045.
Jiangsu Hengrui Pharmaceuticals Co., Ltd., U.S. Agent,
Venus Pharmaceutical Laboratories Inc., 506 Carnegie
Center, Suite 100, Princeton, NJ 08540.
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11080
Federal Register / Vol. 87, No. 39 / Monday, February 28, 2022 / Notices
Therefore, approval of the
applications listed in the table, and all
amendments and supplements thereto,
is hereby withdrawn as of March 30,
2022. 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
without approved new drug
applications violates section 301(a) and
(d) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331(a) and (d)).
Drug products that are listed in the table
that are in inventory on March 30, 2022
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: February 18, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–04153 Filed 2–25–22; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Advisory Commission on Childhood
Vaccines Meeting Cancellation
Health Resources and Services
Administration; Department of Health
and Human Services.
AGENCY:
ACTION:
Notice of meeting cancellation.
This is to notify the public
that the March 3, 2022, meeting of the
Advisory Commission on Childhood
Vaccines (ACCV) is canceled and will
be rescheduled. This meeting was
announced in the Federal Register, Vol.
87, No. 20 on Monday, January 31, 2022
(FR Doc. 2022–01848 Filed 1–28–22).
Future meetings will occur in June,
September, and December of calendar
year 2022 and were announced through
the same Federal Register notice.
SUMMARY:
CDR
Reed Grimes, Designated Federal
Official, ACCV, 5600 Fishers Lane,
Rockville, Maryland 20857, telephone:
(301) 443–6634 or email: ACCV@
HRSA.gov.
khammond on DSKJM1Z7X2PROD with NOTICES
FOR FURTHER INFORMATION CONTACT:
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2022–04105 Filed 2–25–22; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel PAR20–300:
Maternal and Pediatric Pharmacology and
Therapeutics.
Date: March 24, 2022.
Time: 10:00 a.m. to 8:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Dianne Hardy, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6175,
MSC 7892, Bethesda, MD 20892, 301–435–
1154, dianne.hardy@nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel Fellowships:
Population Sciences and Epidemiology.
Date: March 24–25, 2022.
Time: 10:00 a.m. to 7:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Annie Laurie McRee,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 100,
Bethesda, MD 20892, (301) 827–7396,
mcreeal@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel Member
Conflict: Genes, Genomes and Genetics.
Date: March 29, 2022.
Time: 9:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892, (Virtual Meeting).
Contact Person: Guoqin Yu, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Bethesda, MD
20892, (301) 435–1276, guoqin.yu@nih.gov.
PO 00000
Frm 00043
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Name of Committee: Center for Scientific
Review Special Emphasis Panel NIH
Research Enhancement Award (R15) in
Oncological Sciences.
Date: March 30, 2022.
Time: 9:00 a.m. to 8:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892, (Virtual Meeting).
Contact Person: Svetlana Kotliarova, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6214
Bethesda, MD 20892, 301–594–7945,
kotliars@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: February 22, 2022.
David W Freeman,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2022–04127 Filed 2–25–22; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Mental Health;
Notice of Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Mental Health Special Emphasis Panel;
Pathway to Independence Awards (K99/R00,
K22).
Date: March 24, 2022.
Time: 9:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852 (Virtual
Meeting).
Contact Person: David W. Miller, Ph.D.,
Scientific Review Officer, Division of
Extramural Activities, National Institute of
Mental Health, National Institutes of Health,
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[Federal Register Volume 87, Number 39 (Monday, February 28, 2022)]
[Notices]
[Pages 11079-11080]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-04153]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-0030]
Fresenius Kabi USA, LLC, et al.; Withdrawal of Approval of Five
Abbreviated New Drug Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is
withdrawing approval of five 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 March 30, 2022
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 their 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 065408............ Epirubicin Fresenius Kabi USA,
Hydrochloride (HCl) LLC, Three Corporate
Injection, 150 Dr., Lake Zurich, IL
milligrams (mg)/75 60047.
milliliters (mL) (2 mg/
mL), 10 mg/5 mL (2 mg/
mL), 50 mg/25 mL (2 mg/
mL), and 200 mg/100 mL
(2 mg/mL).
ANDA 065411............ Epirubicin HCl Do.
Injection, 200 mg/100
mL (2 mg/mL) and 50 mg/
25 mL (2 mg/mL).
ANDA 065440............ Idarubicin HCl Do.
Injection, 1 mg/mL.
ANDA 077790............ Fludarabine Phosphate Hospira, Inc., 275
for Injection, 50 mg/ North Field Dr., Lake
vial. Forest, IL 60045.
ANDA 091008............ Gabapentin Capsules, Jiangsu Hengrui
100 mg, 300 mg, and Pharmaceuticals Co.,
400 mg. Ltd., U.S. Agent,
Venus Pharmaceutical
Laboratories Inc.,
506 Carnegie Center,
Suite 100, Princeton,
NJ 08540.
------------------------------------------------------------------------
[[Page 11080]]
Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of March
30, 2022. 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 without approved new drug applications violates section 301(a)
and (d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(a)
and (d)). Drug products that are listed in the table that are in
inventory on March 30, 2022 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: February 18, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-04153 Filed 2-25-22; 8:45 am]
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