Health and Human Services Department, Food and Drug Administration
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.
Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services Food and Drug Administration 21 CFR Part 558 [Docket No. FDA-2015-N-0002] AGENCY: Food and Drug Administration, HHS. ACTION: Notification of withdrawal. SUMMARY: 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. ( printed page 78971) DATES: Withdrawal of approval is effective December 31, 2015. 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: 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 …
Other Federal Register documents from the same docket.
New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship
New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship
Conditional Approval of a New Animal Drug No Longer In Effect; Masitinib Mesylate Tablets
Conditional Approval of a New Animal Drug No Longer in Effect; Masitinib
New Animal Drugs for Use in Animal Feeds; Bacitracin Methylenedisalicylate
Citation: 80 FR 78970
