87 FR 39 pg. 11079 - New Animal Drugs; Withdrawal of Approval of New Animal Drug Application
Type: NOTICEVolume: 87Number: 39Page: 11079
Page: 11079Docket number: [Docket No. FDA-2021-N-0002]
FR document: [FR Doc. 2022-03539 Filed 2-25-22; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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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The approval is withdrawn as of February 28, 2022.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, 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(21 CFR 514.116), notice is given that approval of NADA 093-329, and all supplements and amendments thereto, is hereby withdrawn February 28, 2022.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.
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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