Oral Dosage Form New Animal Drugs; Milbemycin Oxime, Lufenuron, and Praziquantel
other · Food and Drug Administration · Rule · Published 2012-01-27 · Effective 2012-01-27 · 77 FR 4225
Document
Document number
2012-1744
Federal Register citation
77 FR 4225
CFR reference
21 CFR 520
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2012-01-27
Effective date
2012-01-27
HHS docket
Docket No. FDA-2011-N-0003
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 the veterinary prescription use of milbemycin oxime, lufenuron, and praziquantel for the prevention of heartworm disease, for prevention and control of fleas, and for the treatment and control of various internal parasites in dogs.