Intramammary Dosage Form New Animal Drugs; Pirlimycin Hydrochloride

Resumo

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 Pharmacia and Upjohn Co. The supplemental NADA provides for use of a sterile solution of pirlimycin hydrochloride for intramammary treatment of clinical and subclinical staphylococcal and streptococcal mastitis in lactating dairy cows, for reduction in the preslaughter withdrawal period, and for revision of the milk discard statement in labeling to state the milk discard time only (i.e., to remove reference to the number of milkings).