Oral Dosage Form New Animal Drugs; Milbemycin Oxime/Lufenuron Tablets
other · Food and Drug Administration · Rule · Published 1997-05-27 · Effective 1997-05-27 · 62 FR 28628
Document
Document number
97-13823
Federal Register citation
62 FR 28628
CFR reference
21 CFR 520
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
1997-05-27
Effective date
1997-05-27
Abstract
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Novartis Animal Health US, Inc. The NADA provides for use of milbemycin oxime/lufenuron tablets for prevention of heartworm disease caused by Dirofilaria immitis, control of adult Ancylostoma caninum, the removal and control of adult Toxocara canis, Toxascaris leonina, and Trichuris vulpis infections, and the prevention and control of flea populations in dogs.