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.
Agency Contact: Joan C. Gotthardt, Center for Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-7571, e-mail: email@example.com.
This rule is final. Its effective date is October 8, 2004.