Ophthalmic and Topical Dosage Form New Animal Drugs; Ivermectin Topical Solution
other · Food and Drug Administration · Rule · Published 2011-12-29 · Effective 2011-12-29 · 76 FR 81806
Document
Document number
2011-33382
Federal Register citation
76 FR 81806
CFR reference
21 CFR 524
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2011-12-29
Effective date
2011-12-29
HHS docket
Docket No. FDA-2011-N-0003
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 Cross Vetpharm Group, 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.