[Federal Register Volume 82, Number 39 (Wednesday, March 1, 2017)]
[Rules and Regulations]
[Pages 12170-12171]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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is hereby withdrawn, effective March 13, 2017.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