Ophthalmic and Topical Dosage Form New Animal Drugs; Ivermectin Topical Solution
other · Food and Drug Administration · Rule · Published 2010-05-12 · Effective 2010-05-12 · 75 FR 26647
Document
Document number
2010-11244
Federal Register citation
75 FR 26647
CFR reference
21 CFR 524
Type
Rule
Action
Final rule, technical amendment.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2010-05-12
Effective date
2010-05-12
HHS docket
Docket No. FDA-2010-N-0002
Abstract
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by First Priority, Inc. The supplemental ANADA adds claims for persistent effectiveness against various species of external and internal parasites when cattle are treated with a topical solution of ivermectin.