New Animal Drugs; Tilmicosin

Samenvatting

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 Elanco Animal Health, A Division of Eli Lilly & Co. The supplemental NADA provides for subcutaneous injection of tilmicosin phosphate solution for the treatment of ovine respiratory disease (ORD). FDA is also amending the regulations to add tolerances for residues of tilmicosin in sheep muscle and liver and in cattle muscle.