Implantation or Injectable Dosage Form New Animal Drugs; Ivermectin
other · Food and Drug Administration · Rule · Published 2009-03-02 · Effective 2009-03-02 · 74 FR 9049
Document
Document number
E9-4304
Federal Register citation
74 FR 9049
CFR reference
21 CFR 522
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2009-03-02
Effective date
2009-03-02
HHS docket
Docket No. FDA-2009-N-0665
Abstract
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental abbreviated new animal drug application (ANADA) filed by IVX Animal Health, Inc. The supplemental ANADA adds claims for persistent effectiveness against various species of external and internal parasites when cattle are treated with a 1-percent ivermectin solution by subcutaneous injection.