FDA Approves Dog, Horse Drugs

Two seperate drugs designed for treatment of otitis externa in dogs and lower respiratory tract infections in horses were approved by the FDA.

The Food and Drug Administration has approved two animal drugs, one for the treatment of otitis externa in dogs and the second for the treatment of lower respiratory tract infections in horses.

Both approvals are effective today.

The first applies to Belgium-based Janssen Pharmaceutica NV’s Surolan (miconazole nitrate, polymixin B sulfate and prednisolone acetate) for veterinary prescription use.

The indications for use say the drug treats canine otitis externa associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Staphylococcus pseudintermedius). Federal law restricts this drug to use by or on the order of a licensed veterinarian.

The second drug applies to Pharmacia & Upjohn Co., a division of Pfizer Inc. of New York, for the veterinarian prescription use of Excede (ceftiofur crystalline free acid) Sterile Suspension. The drug is not to be used in horses intended for human consumption.

The indications for use say the drug treats equine lower respiratory tract infections caused by susceptible strains of Streptococcus equi ssp. zooepidemicus.

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