Document ID: FDA-2017-N-0002-0001
Agency: fda
Document Type: Rule
Title: New Animal Drugs: Withdrawal of Approval of New Animal Drug Application
Posted Date: 2017-03-01T05:00Z

[Federal Register Volume 82, Number 39 (Wednesday, March 1, 2017)]
[Rules and Regulations]
[Pages 12170-12171]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-03931]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 522, and 529

[Docket No. FDA-2017-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 a new animal drug application (NADA) and an abbreviated new animal 
drug application (ANADA) at the sponsors' requests because the products 
are no longer manufactured or marketed.

DATES: Withdrawal of approval is effective March 13, 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,sujaya.dessai@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: The sponsors of the following applications 
have requested that FDA withdraw approval of the NADA and ANADA listed 
in the following table because the products are no longer manufactured 
or marketed:

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                                                                                                      21 CFR
                File No.                            Sponsor                  Product name             section
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135-773.................................  Baxter Healthcare Corp.,    AERRANE (isoflurane USP)..        529.1186
                                           One Baxter Pkwy.,
                                           Deerfield, IL 60015.
200-421.................................  Hospira, Inc., 275 North    Ceftiofur (ceftiofur Na)          522.313c
                                           Field Dr., Lake Forest,     for Injection.
                                           IL 60045.
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[[Page 12171]]

    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 NADA 
135-773 and ANADA 200-421, and all supplements and amendments thereto, 
is hereby withdrawn, effective March 13, 2017.
    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: February 23, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-03931 Filed 2-28-17; 8:45 am]
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