New Animal Drugs; Withdrawal of Approval of New Animal Drug Applications
other · Food and Drug Administration · Rule · Published 2021-02-23 · Effective 2021-02-23 · 86 FR 10819
Document
Document number
2021-03250
Federal Register citation
86 FR 10819
CFR reference
21 CFR 510
Type
Rule
Action
Notification of withdrawal.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2021-02-23
Effective date
2021-02-23
HHS docket
Docket No. FDA-2019-N-5405
Abstract
The Food and Drug Administration (FDA) is withdrawing approval of seven new animal drug applications (NADAs) from multiple holders of these applications. The basis for the withdrawals is that the holders of these applications have repeatedly failed to file required annual reports for the applications.