Rules and Regulations. Notification of withdrawal

Agency: Food and Drug Administration, HHS
Action: Notification of withdrawal
Citation: FR Doc. 2017-03678 · Docket No. FDA-2016-N-0002 · 21 CFR 524

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.

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(21 CFR 514.116), notice is given that approval of ANADA 200-524, and all supplements and amendments thereto, is hereby withdrawn, effective March 6, 2017.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. [FR Doc. 2017-03678 Filed 2-23-17; 8:45 am]