Implantation or Injectable Dosage Form New Animal Drugs; Ivermectin
other · Food and Drug Administration · Rule · Published 2007-11-07 · Effective 2007-11-07 · 72 FR 62771
Document
Document number
E7-21839
Federal Register citation
72 FR 62771
CFR reference
21 CFR 522
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2007-11-07
Effective date
2007-11-07
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 one percent ivermectin solution by subcutaneous injection.