New Animal Drugs for Use in Animal Feeds; Tiamulin
other · Food and Drug Administration · Rule · Published 2009-01-02 · Effective 2009-01-02 · 74 FR 6
Document
Document number
E8-31128
Federal Register citation
74 FR 6
CFR reference
21 CFR 558
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2009-01-02
Effective date
2009-01-02
HHS docket
Docket No. FDA-2008-N-0039
Abstract
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of two supplemental new animal drug applications (NADAs) filed by Novartis Animal Health US, Inc. The supplemental NADAs provide for removal of a 250-pound weight restriction and the addition of a reproductive caution statement to labeling of tiamulin medicated feeds used for the treatment or control of certain bacterial enteric diseases in swine.