New Animal Drugs; Withdrawal of Approval of New Animal Drug Applications
other · Food and Drug Administration · Rule · Published 2016-12-27 · Effective 2016-12-30 · 81 FR 95025
Document
Document number
2016-31082
Federal Register citation
81 FR 95025
CFR reference
21 CFR 558
Type
Rule
Action
Notification of withdrawal.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2016-12-27
Effective date
2016-12-30
HHS docket
Docket No. FDA-2016-N-0002
Abstract
The Food and Drug Administration (FDA) is withdrawing approval of 11 new animal drug applications (NADAs) and 4 abbreviated new animal drug applications (ANADAs). These withdrawals of approval of NADAs and ANADAs for antimicrobial drugs of importance to human medicine that are administered to food-producing animals in medicated feed are being made because the products are no longer being manufactured or marketed. These actions are consistent with the FDA Center for Veterinary Medicine's initiative for the Judicious Use of Antimicrobials.