Determination of Regulatory Review Period for Purposes of Patent Extension; TYZEKA
The Food and Drug Administration (FDA) has determined the regulatory review period for TYZEKA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submissions of applications to the Director of Patents and Trademarks, Department of Commerce, for the extension of patents which claim that human drug product.
Implantation or Injectable Dosage Form New Animal Drugs; Flunixin
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental abbreviated new animal drug application (ANADA) filed by IVX Animal Health, Inc. The supplemental ANADA provides for the veterinary prescription use of flunixin meglumine solution by intravenous injection in lactating dairy cattle for control of pyrexia associated with acute bovine mastitis.