Health and Human Services Department, Food and Drug Administration
The Food and Drug Administration (FDA) is withdrawing approval of a new animal drug application (NADA) at the sponsor's request because the product is 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 [Docket No. FDA-2021-N-0002] 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) at the sponsor's request because the product is no longer manufactured or marketed. DATES: The approval is withdrawn as of February 28, 2022. 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: Elanco US Inc., 2500 Innovation Way, Greenfield, IN 46140, has requested that FDA withdraw approval of NADA 093-329 for use of a prolonged-release bolus containing sulfamethazine in cattle because the product is no longer manufactured or marketed. Therefore, under authority delegated to the Commissioner of Food and Drugs and in accordance with § 514.116 Notice of withdrawal of approval of application ( 21 CFR 514.116 ), notice is given that approval of NADA 093-329, and all supplements and amendments thereto, is hereby withdrawn February 28, 2022. Elsewhere in this issue of the Federal Register , FDA is amending the animal drug regulations to reflect the voluntary withdrawal of approval of this application. Dated: February 14, 2022. Lauren K. Roth, Associate Commissioner for Policy. [ FR Doc. 2022-03539 Filed 2-25-22…
Other Federal Register documents from the same docket.
New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor
New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of a New Animal Drug Application; Change of Sponsor
New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsor Address
New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship
Citation: 87 FR 11079
