83 FR 13637 - New Animal Drugs; Withdrawal of Approval of New Animal Drug Applications

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 62 (March 30, 2018)

The Food and Drug Administration (FDA) is withdrawing approval of three new animal drug applications (NADAs). This action is being taken at the sponsors' request because these products are no longer manufactured or marketed.

[Federal Register Volume 83, Number 62 (Friday, March 30, 2018)]
[Rules and Regulations]
[Pages 13637-13638]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-06357]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522

[Docket No. FDA-2017-N-0002]


New Animal Drugs; Withdrawal of Approval of New Animal Drug 
Applications

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 three new animal drug applications (NADAs). This action is being 
taken at the sponsors' request because these products are no longer 
manufactured or marketed.

DATES: Withdrawal of approval is effective April 9, 2018.

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: During July and August 2017, the following 
sponsors requested that FDA withdraw approval of the NADAs listed in 
the following table because the products are no longer manufactured or 
marketed:

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              File No.                           Sponsor                    Product name          21 CFR section
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047-055.............................  Watson Laboratories, Inc.,    Chorionic Gonadotropin              522.1081
                                       311 Bonnie Circle, Corona,    Powder for Injection.
                                       CA 92880.

[[Page 13638]]

 
104-606.............................  Watson Laboratories, Inc.,    Dexamethasone Sodium                 522.540
                                       311 Bonnie Circle, Corona,    Phosphate Injection.
                                       CA 92880.
139-633.............................  Wildlife Laboratories, Inc.,  WILDNIL (carfentanil                 522.300
                                       1230 W. Ash St., suite D,     citrate) Injection.
                                       Windsor, CO 80550.
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    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 NADAs 047-055, 104-606, and 139-633, and all supplements and 
amendments thereto, is hereby withdrawn, effective April 9, 2018.
    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: March 21, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-06357 Filed 3-29-18; 8:45 am]
 BILLING CODE 4164-01-P