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

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Start Preamble

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notification of withdrawal.

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.

Start Further Info

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.

End Further Info End Preamble Start Supplemental Information

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:

File No.SponsorProduct name21 CFR section
047-055Watson Laboratories, Inc., 311 Bonnie Circle, Corona, CA 92880Chorionic Gonadotropin Powder for Injection522.1081
Start Printed Page 13638
104-606Watson Laboratories, Inc., 311 Bonnie Circle, Corona, CA 92880Dexamethasone Sodium Phosphate Injection522.540
139-633Wildlife Laboratories, Inc., 1230 W. Ash St., suite D, Windsor, CO 80550WILDNIL (carfentanil citrate) Injection522.300

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is given that approval of NADAs 047-055, 104-606, and 139-633, and all supplements and amendments thereto, is hereby withdrawn, effective April 9, 2018.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.

Start Signature

Dated: March 21, 2018.

Leslie Kux,

Associate Commissioner for Policy.

End Signature End Supplemental Information

[FR Doc. 2018-06357 Filed 3-29-18; 8:45 am]

BILLING CODE 4164-01-P