New Animal Drugs for Use in Animal Feeds; Bacitracin Methylenedisalicylate
other · Food and Drug Administration · Rule · Published 2015-12-22 · Effective 2015-12-22 · 80 FR 79474
Document
Document number
2015-32000
Federal Register citation
80 FR 79474
CFR reference
21 CFR 558
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2015-12-22
Effective date
2015-12-22
HHS docket
Docket No. FDA-2015-N-0002
Abstract
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Pharmgate LLC for the use of a Type A medicated article containing bacitracin methylenedisalicylate to manufacture Type B and Type C medicated feeds for chickens, turkeys, pheasants, quail, and feedlot cattle. This supplemental approval reflects FDA's effectiveness conclusions that relied on the National Academy of Sciences/National Research Council Drug Efficacy Study Group's evaluation of the effectiveness of this drug as well indications for use not subject to this review.