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FDA warns of importing, compounding trilostane
FDA warns against importation or compounding of trilostane following the approval of Vetoryl.
-- The U.S. Food and Drug Administration (FDA) sent an open letter to veterinarians Sept. 11, announcing the approval of a new drug to treat Cushing’s disease and warning against continued importation or compounding of its active ingredient.
Vetoryl, distributed by Dechra, recently was approved by the FDA to treat pituitary-dependent and adrenal-dependent hyperadrenocorticism (Cushing’s disease) in dogs. It is the only FDA-approved animal drug containing trilostane as its active ingredient, notes the FDA.
The agency adds that, now that Vetoryl is approved for use and available to veterinarians, they should cease imports of trilostane and refrain from compounding it.
“In prescribing FDA-approved Vetoryl to treat Cushing’s disease, you are providing your clients and their dogs with the only trilostane product that has demonstrated safety and effectiveness in dogs and whose manufacturing process met FDA standards for quality, purity, and potency,” the letter states.
In cases where specific patients require greater strengths of trilostane than Vetoryl offers, FDA says it can be legally compounded, but only using FDA-approved Vetoryl as the starting material.More information on compounding is available here.