2017-03678. New Animal Drugs; Withdrawal of Approval of a New Animal Drug Application

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notification of withdrawal.

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, [e-mail].

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 § 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(21 CFR 514.116), notice is given that approval of ANADA 200-524, and all supplements and amendments thereto, is hereby withdrawn, effective March 6, 2017.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.