FDA Approves Release of Vetoryl in Larger Capsule Size

Dechra Veterinary Products LLC announced that their company has received FDA approval to market a larger size (120 mg) of Vetoryl, their trilostane product. This is a welcome addition that will be useful when treating larger dogs with Cushing's syndrome. We now have the same 4 capsule sizes of the drug available in the USA (10-mg, 30-mg, 60-mg, and 120-mg) that veterinarians in Europe have had for some time.

Read the text of the full Press Release below, or visit the News page on the Dechra website to view the original Press Release.

DECHRA RECEIVES SUPPLEMENTAL FDA APPROVAL FOR 

120 MG VETORYL (TRILOSTANE) CAPSULES

OVERLAND PARK, KS, NOVEMBER, 2011 – Dechra Veterinary Products LLC announces the company has received supplemental FDA approval to market 120 mg VETORYL Capsules.

VETORYL, which contains the active ingredient trilostane, is the only FDA approved product indicated for use in pituitary-dependent and adrenal-dependent hyperadrenocorticism (Cushing's syndrome) in dogs. VETORYL is now approved in 10 mg, 30 mg, 60 mg and 120 mg capsules.

“This is great news for the veterinary industry,” said Mike Eldred, President of U.S. Operations. “Having approval for the 10 mg, 30 mg, 60 mg and now 120 mg capsules provides veterinarians with more dosing options and flexibility to treat all sizes of dogs.”

“Now that we have FDA approved trilostane,” said John Angus, DVM, DACVD, “I would recommend against compounding due to variability in the product, not just between compounding pharmacies, but sometimes between batches from the same compounding pharmacy. A study presented at ACVIM 2010 found a tremendous range in the amount of actual active drug compared to what was on the label (1). This can be a problem when trying to regulate a Cushing’s case. Compounding pharmacies provide valuable services and can help in a lot of patients; however, this is not a drug that I would get compounded unless the compounding company is using the FDA approved trilostane (VETORYL Capsules) from Dechra.”

Dechra Veterinary Products LLC, located in Overland Park, Kansas is the U.S. subsidiary of Dechra Pharmaceuticals PLC, a UK listed company focused on international animal healthcare markets. Dechra currently markets a range of specialized veterinary approved products in the U.S. For more information, please visit www.dechra-us.com or call 866-933-2472.

Reference

1. Cook AK, Nieuwoudt CD, Longhofer SL, et al. Evaluation of Content of Compounded Trilostane Products. 2010 ACVIM Forum Abstract #46.