Oral Dosage Form New Animal Drugs; Ivermectin With Pyrantel Pamoate
other · US Department of Health and Human Services · Rule · Published 1996-11-20 · 61 FR 59003
Document
Document number
96-29631
Federal Register citation
61 FR 59003
CFR reference
21 CFR 520
Type
Rule
Action
Final rule.
Category
other
Sub-agency
US Department of Health and Human Services
Publication date
1996-11-20
Abstract
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Merck Research Laboratories, Division of Merck & Co., Inc., for chewable tablets containing ivermectin with pyrantel pamoate. The product is used to prevent canine heartworm disease and to treat and control ascarid and hookworm infections. The supplemental NADA provides for expanding the use for the treatment and control of an additional adult hookworm infection.