Oral Dosage Form New Animal Drugs; Firocoxib Tablets
other · Food and Drug Administration · Rule · Published 2008-01-16 · Effective 2008-01-16 · 73 FR 2808
Document
Document number
E8-730
Federal Register citation
73 FR 2808
CFR reference
21 CFR 520
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2008-01-16
Effective date
2008-01-16
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 Merial Ltd. The supplemental NADA provides for veterinary prescription use of firocoxib chewable tablets in dogs for the control of postoperative pain and inflammation associated with soft-tissue surgery.