Animal drug regulations have been amended for a new dosage range and added pathogens for micotil 300 this week by the Food and Drug Administration.
A supplemental new animal drug application (NADA), filed by Elanco Animal Health, a division of Eli Lilly and Co., provides a dose range and adds pathogens for the use of an injectable solution of tilmicosin phosphate for treatment of respiratory disease in cattle and the treatment of respiratory disease in sheep. This drug is available by veterinary prescription. As a consequence of revising the dosage, the preslaughter withdrawal period has been recalculated.
The supplemental NADA is approved as of Dec. 30, 2009, and qualifies for three years of marketing exclusivity.