Oral Dosage Form New Animal Drugs; Ivermectin Tablets and Chewables
other · Food and Drug Administration · Rule · Published 2004-07-22 · Effective 2004-07-22 · 69 FR 43735
Document
Document number
04-16627
Federal Register citation
69 FR 43735
CFR reference
21 CFR 520
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2004-07-22
Effective date
2004-07-22
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 Phoenix Scientific, Inc. The ANADA provides for veterinary prescription use of chewable ivermectin tablets in dogs to prevent canine heartworm disease by eliminating the tissue stage of heartworm larvae (Dirofilaria immitis) for 1 month (30 days) after infection.