Zoetis Inc., et al.; Withdrawal of Approval of New Animal Drug Applications for Combination Drug Medicated Feeds Containing an Arsenical Drug
other · Food and Drug Administration · Rule · Published 2014-02-27 · Effective 2014-03-10 · 79 FR 10976
Document
Document number
2014-02617
Federal Register citation
79 FR 10976
CFR reference
21 CFR 556
Type
Rule
Action
Final rule; technical amendments.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2014-02-27
Effective date
2014-03-10
HHS docket
Docket No. FDA-2014-N-0002
Abstract
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal of approval of 69 new animal drug applications (NADAs) and 22 abbreviated new animal drug applications (ANADAs) for use of arsanilic acid, carbarsone, or roxarsone Type A medicated articles to manufacture combination drug Type B and Type C medicated feeds. This action is being taken at the sponsor's request because the products are no longer manufactured or marketed. FDA is also amending the animal drug regulations to remove entries describing conditions of use for combination drug medicated feeds for which no NADA is approved. This action is being taken to improve the accuracy of the regulations.