Animal Drugs, Feeds, and Related Products; Gentamicin Injection

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the following actions on two new animal drug applications (NADA's) held by Schering-Plough Animal Health: The combination of two NADA's into one and the withdrawal of the other, the codification of a supplemental NADA approved by letter, the approval of a supplemental NADA that provides for the use of two higher product - concentrations at the same dosage and for the same indications, and the addition of a tolerance for residues of gentamicin in chickens. The approved, combined, and supplemented NADA provides for use of gentamicin sulfate injection for the prevention of early mortality of day-old chickens and 1- to 3-day-old turkeys due to certain infections susceptible to gentamicin.