FDA OKs Phoenix Scientific sANADA for Canine Otitis Externa
02/18/2005
Federal Register Final rule: FDA is amending the animal drug regulations to reflect approval of a supplemental abbreviated new animal drug application (ANADA) filed by Phoenix Scientific, Inc. for a new container size, a 20 g dropper bottle, from which gentamicin sulfate, betamethasone valerate, clotrimazole ointment may be administered for treating acute and chronic canine otitis externa. The regulations are also being amended to correct the indications for use to agree with approved product labeling. To view this final rule, click here.
