Implantation and Injectable Dosage Form New Animal Drugs; Firocoxib
other · Food and Drug Administration · Rule · Published 2010-09-28 · Effective 2010-09-28 · 75 FR 59610
Document
Document number
2010-24254
Federal Register citation
75 FR 59610
CFR reference
21 CFR 522
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2010-09-28
Effective date
2010-09-28
HHS docket
Docket No. FDA-2010-N-0002
Abstract
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original new animal drug application (NADA) filed by Merial Ltd. The NADA provides for the veterinary prescription use of firocoxib injectable solution in horses for the control of pain and inflammation associated with osteoarthritis.