New Animal Drugs; Withdrawal of Approval of New Animal Drug Application, 11079 [2022-03539]
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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]
BILLING CODE 4164–01–P
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DATES: The approval is withdrawn as of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
BILLING CODE 4164–01–P
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 ....
VerDate Sep<11>2014
17:23 Feb 25, 2022
Jkt 256001
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
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.
E:\FR\FM\28FEN1.SGM
28FEN1
]]>Agencies
[Federal Register Volume 87, Number 39 (Monday, February 28, 2022)]
[Notices]
[Page 11079]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-03539]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-0002]
New Animal Drugs; Withdrawal of Approval of New Animal Drug
Application
AGENCY: Food and Drug Administration, HHS.
ACTION: Notification of withdrawal.
-----------------------------------------------------------------------
SUMMARY: 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, [email protected].
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 Sec. 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.
Dated: February 14, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-03539 Filed 2-25-22; 8:45 am]
BILLING CODE 4164-01-P
