Ophthalmic and Topical Dosage Form New Animal Drugs; Milbemycin Oxime Solution
other · Food and Drug Administration · Rule · Published 2001-03-08 · Effective 2001-03-08 · 66 FR 13848
Document
Document number
01-5684
Federal Register citation
66 FR 13848
CFR reference
21 CFR 524
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2001-03-08
Effective date
2001-03-08
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 Novartis Animal Health US, Inc. The supplemental NADA provides for veterinary prescription use of milbemycin oxime solution to treat ear mite infestations in cats and kittens 4 weeks of age and older and for a repeat treatment, if necessary.