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Food and Drug Administration, HHS.
Notification of withdrawal.
The Food and Drug Administration (FDA) is withdrawing approval of three new animal drug applications (NADAs) providing for the use of nitarsone in medicated feed for chickens and turkeys. This action is being taken at the sponsor's request because these products are no longer manufactured or marketed.
Withdrawal of approval is effective December 31, 2015.
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.
Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007 has requested that FDA withdraw approval of the following NADAs that provide for the use of nitarsone in medicated feed for chickens and turkeys because the products are no longer manufactured or marketed:
| File No. | Product name | 21 CFR Section |
|---|---|---|
| 007-616 | HISTOSTAT 50 (nitarsone) Type A Medicated Article | 558.369 |
| 141-088 | HISTOSTAT 50 (nitarsone)/BMD (bacitracin methylene disalicylate) | 558.369 |
| 141-132 | HISTOSTAT 50/ALBAC (bacitracin zinc) | 558.369 |
Therefore, under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, and in accordance with 21 CFR 514.116 Notice of withdrawal of approval of application, notice is given that approval of NADAs 007-616, 141-088, and 141-132, and all supplements and amendments thereto, is hereby withdrawn, effective December 31, 2015.
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: December 11, 2015.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2015-31828 Filed 12-17-15; 8:45 am]
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