Ophthalmic and Topical Dosage Form New Animal Drugs; Cyclosporine
other · Food and Drug Administration · Rule · Published 1997-09-18 · Effective 1997-09-18 · 62 FR 48940
Document
Document number
97-24850
Federal Register citation
62 FR 48940
CFR reference
21 CFR 524
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
1997-09-18
Effective date
1997-09-18
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 Schering-Plough Animal Health. The supplemental NADA provides for use of cyclosporine ophthalmic ointment on dogs for management of chronic superficial keratitis (CSK) and changing the approved label claim to management of chronic keratoconjunctivitis sicca (KCS).