Ophthalmic and Topical Dosage Form New Animal Drugs; Miconazole, Polymixin B, and Prednisolone Suspension

摘要

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Janssen Pharmaceutica NV. The NADA provides for use of miconazole nitrate, polymixin B sulfate, and prednisolone acetate for the treatment of otitis externa in dogs.