September 11, 2009
Dear Pharmacy Professional:
We are writing to you about the recent approval by the U.S. Food and Drug Administration (FDA) of VETORYL (trilostane) Capsules for the treatment of pituitary-dependent and adrenal-dependent hyperadrenocorticism (Cushing’s disease) in dogs. Please see the approval announcement at http://www.fda.gov/AnimalVeterinary/NewsEvents/ CVMUpdates/ucm150265.htm.
VETORYL, distributed by Dechra, Ltd., is available in the U.S. in 10, 30, and 60 mg strength capsules. It is the only FDA-approved animal drug that contains trilostane as the active ingredient. Now that VETORYL is approved and available for veterinary use in the U.S., trilostane should not be imported from other countries or compounded from bulk.
Each FDA-approved animal drug goes through a rigorous evaluation process, and prior to approval, is clinically tested for safety and effectiveness in the target animal species. In addition, the FDA thoroughly inspects and evaluates the adequacy of the manufacturing process to ensure that the drug’s identity, strength, quality, and purity are preserved. The FDA continues to monitor the drug’s quality and safety after it is approved. An animal drug that is compounded from bulk drug ingredients is not FDA-approved, and therefore, the safety and effectiveness of the compounded drug, as well as the adequacy of the manufacturing process, have not been evaluated.
There may be instances where you may be asked to compound trilostane for specific patients that require the drug in strengths or forms that are not offered by VETORYL. In these limited cases, trilostane can only be legally compounded if it is done by or on the order of a licensed veterinarian within the practice of veterinary medicine, and if the FDA-approved VETORYL is used as the starting material. Additional requirements and information on legal animal drug compounding are available in Title 21, Code of Federal Regulations, Section 530.13 (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=530&showFR=1).
At the FDA’s Center for Veterinary Medicine (CVM), we are committed to promoting and protecting animal health by ensuring that safe and effective drugs are available for veterinary use.
For more information, please contact the Communications Staff at CVM at 240-402-7002 or AskCVM@fda.hhs.gov.
The FDA’s Center for Veterinary Medicine