Notice2022-03539
New Animal Drugs; Withdrawal of Approval of New Animal Drug Application
Primary source
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Published
February 28, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 39 (Monday, February 28, 2022)</title>
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[Federal Register Volume 87, Number 39 (Monday, February 28, 2022)]
[Notices]
[Page 11079]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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.
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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DATES: The approval is withdrawn as of February 28, 2022.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, <a href="/cdn-cgi/l/email-protection#f083859a918991de949583839199b0969491de989883de979f86"><span class="__cf_email__" data-cfemail="83f0f6e9e2fae2ade7e6f0f0e2eac3e5e7e2adebebf0ade4ecf5">[email protected]</span></a>.
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withdrawn February 28, 2022.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
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