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FDA Codifies Ophthalmic Solution for Dogs

09/08/2010

Federal Register Final rule: FDA is amending the animal drug regulations to codify the conditions of use of an approved NADA for gentamicin sulfate and betamethasone acetate ophthalmic solution. Each milliliter (mL) of solution contains gentamicin sulfate equivalent to 3 mg of gentamicin base and 1 mg betamethasone acetate equivalent to 0.89 mg betamethasone alcohol. For use in dogs: (1) Amount: Instill one or two drops of solution in the conjunctival sac three or four times a day; (2) Indications for use: For treatment of external bacterial infections of the eye (conjunctiva and cornea); (3) Limitations: Federal law restricts this drug to use by or on the order of a licensed veterinarian. To view this final rule, click here.

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