Document ID: FDA-2021-N-0002-0044
Agency: fda
Document Type: Notice
Title: New Animal Drugs; Withdrawal of Approval of New Animal Drug Application
Posted Date: 2022-02-28T05:00Z

[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.

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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DATES: The approval is withdrawn as of February 28, 2022.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, [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withdrawn February 28, 2022.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]
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