FDA providing guidance on use of drug for Cushing disease

Federal drug authorities are providing guidance for veterinarians on the use and compounding of a drug used in the treatment of hyperadrenocorticism (Cushing disease) in dogs.

The Food and Drug Administration published online a letter to veterinarians Sept. 11 that states Vetoryl is the only FDA-approved animal drug containing trilostane as the active ingredient. The letter also states the drug should not be imported from other countries, should not be compounded in bulk, and can be legally compounded only if Vetoryl is used as the starting material.

“An animal drug that is compounded from bulk drug ingredients is not FDA-approved and the safety and effectiveness of the compounded drug, as well as the adequacy of the manufacturing process, have not been evaluated,” the letter states.

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