Ophthalmic and Topical Dosage Form New Animal Drugs; Diclofenac
other · Food and Drug Administration · Rule · Published 2004-07-07 · Effective 2004-07-07 · 69 FR 40766
Document
Document number
04-15426
Federal Register citation
69 FR 40766
CFR reference
21 CFR 524
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2004-07-07
Effective date
2004-07-07
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 IDEXX Pharmaceuticals, Inc. The NADA provides for topical use of diclofenac cream in horses for the control of pain and inflammation associated with osteoarthritis in tarsal, carpal, metacarpophalangeal, metatarsophalangeal, and proximal interphalangeal (hock, knee, fetlock, and pastern) joints.