Implantation and Injectable Dosage Form New Animal Drugs; Oxytetracycline Injection; Technical Amendment

Riepilogo

The Food and Drug Administration (FDA) is amending the animal drug regulations to include a limitation in the approval of Pliva d.d.'s abbreviated new animal drug application (ANADA). The regulation did not state that use of Pliva d.d.'s oxytetracycline injection in cattle is limited to use in nonlactating dairy cattle. At this time, the regulation is amended to reflect the limitation.