Ophthalmic and Topical Dosage Form New Animal Drugs; Ivermectin Topical Solution
other · Food and Drug Administration · Rule · Published 2007-02-12 · Effective 2007-02-12 · 72 FR 6463
Document
Document number
E7-2368
Federal Register citation
72 FR 6463
CFR reference
21 CFR 524
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2007-02-12
Effective date
2007-02-12
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 Norbrook Laboratories, Ltd. 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.