82 FR 39 pgs. 12170-12171 - New Animal Drugs; Withdrawal of Approval of a New Animal Drug Application
Type: RULEVolume: 82Number: 39Pages: 12170 - 12171
Pages: 12170, 12171Docket number: [Docket No. FDA-2017-N-0002]
FR document: [FR Doc. 2017-03931 Filed 2-28-17; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
[top]
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, sujaya.dessai@fda.hhs.gov .
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 |
[top]
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notice is given that approval of NADA 135-773 and ANADA 200-421, and all supplements and amendments thereto, is hereby withdrawn, effective March 13, 2017.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]
BILLING CODE 4164-01-P