Oral Dosage Form New Animal Drugs; Ivermectin Paste
other · Food and Drug Administration · Rule · Published 2008-06-17 · Effective 2008-06-17 · 73 FR 34184
Document
Document number
E8-13607
Federal Register citation
73 FR 34184
CFR reference
21 CFR 520
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2008-06-17
Effective date
2008-06-17
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 Cross Vetpharm Group Ltd. The supplemental ANADA adds effectiveness claims against various species of internal parasites when horses are treated with ivermectin paste.