Ophthalmic and Topical Dosage Form New Animal Drugs; Gentamicin Otic Solution

摘要

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 use of gentamicin sulfate and betamethasone valerate otic solution to treat acute and chronic canine otitus externa and canine and feline superficial infected lesions caused by bacteria sensitive to gentamicin.