Rules and Regulations. Notification of withdrawal

Agency: Food and Drug Administration, HHS
Action: Notification of withdrawal
Citation: FR Doc. 2017-03931 · Docket No. FDA-2017-N-0002 · 21 CFR 510, 522, 529

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.

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: File No. Sponsor Product name 21 CFR section 135-773 Baxter Healthcare Corp., One Baxter Pkwy., Deerfield, IL 60015 AERRANE (isoflurane USP) 529.1186 200-421 Hospira, Inc., 275 North Field Dr., Lake Forest, IL 60045 Ceftiofur (ceftiofur Na) for Injection 522.313c 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notice is given that approval of NADA 135-773 and ANADA 200-421, and all supplements and amendments thereto, is hereby withdrawn, effective March 13, 2017.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]