Ophthalmic and Topical Dosage Form New Animal Drugs; Gentamicin Sulfate, Betamethasone Valerate, and Clotrimazole Ointment

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The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by Med-Pharmex, Inc. The ANADA provides for the use of gentamicin sulfate, betamethasone valerate, and clotrimazole (Tri-Otic ointment) for the treatment of canine acute and chronic otitis externa associated with yeast and/or bacteria susceptible to gentamicin.