82 FR 11509 - New Animal Drugs; Withdrawal of Approval of a New Animal Drug Application

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 36 (February 24, 2017)

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.

[Federal Register Volume 82, Number 36 (Friday, February 24, 2017)]
[Rules and Regulations]
[Page 11509]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-03678]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 524

[Docket No. FDA-2016-N-0002]


New Animal Drugs; Withdrawal of Approval of a 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 March 6, 2017.

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: Putney, Inc., One Monument Square, Suite 
400, Portland, ME 04101 has requested that FDA withdraw approval of 
ANADA 200-524 for Mupirocin Ointment 2% because the product is no 
longer manufactured or marketed.
    Therefore, under authority delegated to the Commissioner of Food 
and Drugs and redelegated to the Center for Veterinary Medicine, 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 
200-524, and all supplements and amendments thereto, is hereby 
withdrawn, effective March 6, 2017.
    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 21, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-03678 Filed 2-23-17; 8:45 am]
 BILLING CODE 4164-01-P