Ophthalmic and Topical Dosage Form New Animal Drugs; Gentamicin Sulfate, Mometasone Furoate, Clotrimazole Otic Suspension

摘要

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 Schering-Plough Animal Health Corp. The supplemental NADA provides for the addition of once-daily administration to the dosage regimens for gentamicin/mometasone/ clotrimazole otic suspension used to treat otitis externa in dogs and for revision of the indications to reflect a current format.