other · Food and Drug Administration · Rule · Published 2004-10-08 · Effective 2004-10-08 · 69 FR 60308
Document
Document number
04-22606
Federal Register citation
69 FR 60308
CFR reference
21 CFR 522
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2004-10-08
Effective date
2004-10-08
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 Schering-Plough Animal Health Corp. The supplemental NADA provides for the veterinary prescription use of flunixin meglumine solution by intravenous injection in lactating dairy cattle for control of pyrexia associated with bovine respiratory disease and endotoxemia, and for control of inflammation in endotoxemia. It also provides for the veterinary prescription use of flunixin meglumine solution by intravenous injection for control of pyrexia associated with acute bovine mastitis and for the establishment of a tolerance for residues of flunixin in milk.