Health and Human Services Department, Food and Drug Administration
The Food and Drug Administration (FDA) is withdrawing approval of an abbreviated new animal drug application (ANADA) 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 21 CFR Part 520 [Docket No. FDA-2020-N-0002] AGENCY: Food and Drug Administration, HHS. ACTION: Notification of withdrawal. SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval of an abbreviated new animal drug application (ANADA) at the sponsor's request because the product is no longer manufactured or marketed. DATES: Withdrawal of approval is effective July 28, 2020. 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: Hikma International Pharmaceuticals LLC, P.O. Box 182400, Bayader Wadi Seer, Amman, Jordan 11118, has requested that FDA withdraw approval of ANADA 200-323 for use of a 1-gram bolus of phenylbutazone in horses 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21 CFR 514.116 ), notice is given that approval of ANADA 200-323, and all supplements and amendments thereto, is hereby withdrawn, effective July 28, 2020. 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: July 15, 2020. Lauren K. Roth, Associate Co…
Other Federal Register documents from the same docket.
New Animal Drugs; Approval of New Animal Drug Applications
New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship; Change of Sponsor's Name and Address
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 New Animal Drug Applications; Change of Sponsor
Citation: 85 FR 45311
