Page Range | 12170-12171 | |
FR Document | 2017-03931 |
[Federal Register Volume 82, Number 39 (Wednesday, March 1, 2017)] [Rules and Regulations] [Pages 12170-12171] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-03931] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510, 522, and 529 [Docket No. FDA-2017-N-0002] 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 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. 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: 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: ---------------------------------------------------------------------------------------------------------------- 21 CFR File No. Sponsor Product name section ---------------------------------------------------------------------------------------------------------------- 135-773................................. Baxter Healthcare Corp., AERRANE (isoflurane USP).. 529.1186 One Baxter Pkwy., Deerfield, IL 60015. 200-421................................. Hospira, Inc., 275 North Ceftiofur (ceftiofur Na) 522.313c Field Dr., Lake Forest, for Injection. IL 60045. ---------------------------------------------------------------------------------------------------------------- [[Page 12171]] Therefore, under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, and in accordance with Sec. 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notice is given that approval of NADA 135-773 and ANADA 200-421, and all supplements and amendments thereto, is hereby withdrawn, effective March 13, 2017.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] BILLING CODE 4164-01-P
Category | Regulatory Information | |
Collection | Federal Register | |
sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
Publisher | Office of the Federal Register, National Archives and Records Administration | |
Section | Rules and Regulations | |
Action | Notification of withdrawal. | |
Dates | Withdrawal of approval is effective March 13, 2017. | |
Contact | Sujaya Dessai, Center for Veterinary Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5761,[email protected] | |
FR Citation | 82 FR 12170 | |
CFR Citation | 21
CFR
510 21 CFR 522 21 CFR 529 |