Document ID: FDA-2020-N-0002-0001
Agency: fda
Document Type: Rule
Title: New Animal Drugs; Withdrawal of Approval of Abbreviated New Animal Drug Application
Posted Date: 2020-07-28T04:00Z

[Federal Register Volume 85, Number 145 (Tuesday, July 28, 2020)]
[Rules and Regulations]
[Page 45311]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-15761]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520

[Docket No. FDA-2020-N-0002]

New Animal Drugs; Withdrawal of Approval of Abbreviated 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 an abbreviated new animal drug application (ANADA) at the sponsor's 
request because the product is no longer manufactured or marketed.

DATES: Withdrawal of approval is effective July 28, 2020.

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: Hikma International Pharmaceuticals LLC, 
P.O. Box 182400, Bayader Wadi Seer, Amman, Jordan 11118, has requested 
that FDA withdraw approval of ANADA 200-323 for use of a 1-gram bolus 
of phenylbutazone in horses 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 ANADA 200-323, and all supplements and amendments thereto, is hereby 
withdrawn, effective July 28, 2020.
    Elsewhere in this issue of the Federal Register, FDA is amending 
the animal drug regulations to reflect the voluntary withdrawal of 
approval of these applications.

    Dated: July 15, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-15761 Filed 7-27-20; 8:45 am]
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