Vetoryl® (trilostane) Capsules
Vetoryl® (trilostane) Capsules are not currently approved by the FDA, however, Dechra Pharmaceuticals is currently pursuing US FDA approval. Vetoryl Capsules can be legally imported into the US to treat hyperadrenocorticism (Cushing’s syndrome) by following the importation procedure below:
US Importation process from the UK
Vetoryl® (trilostane) Capsules are available in 10 mg, 30 mg, 60 mg and 120 mg capsules in Europe from Dechra Veterinary Products, e-mail: enquiries@dechra-uk.com or from Masters Marketing. If ordering these from the U.S., you have to obtain FDA approval as follows:
Medically Necessary Personal Veterinary Imports
Please submit a letter to:
U.S. Food & Drug Administration
Center for Veterinary Medicine
Attn: Michael L. Zimmerman
7519 Standish Place
MPN-4, RM-109, HFV-235
Rockville, MD 20855
Tel: (240) 276-9202
Please determine the following in the initial contact:
How did the veterinarian learn of this product? If there is any indication that the product has been actively promoted in U.S. markets it will be refused entry and an import alert will be issued.
Please submit the following information:
- Veterinarian’s name
- Clinic’s name, address and phone number
- Client’s name and address
- Patient name and non-food species
- Name of drug
- Drug family or class
- Name and address of drug supplier
- Legal status of the drug in the foreign county
- Amount of drug to be imported, this must be small, non-commercial quantities. Please be sure to specify the number of mg as well as the number of packs (each pack contains 30 Vetoryl Capsules)
- Disease/condition to be treated
- Reason why an approved human or animal drug will not treat the disease condition
- A statement that:
- you will notify the animal owner that the drug is not approved
- that the drug will not be used in any food animal
- and that you agree to notify the FDA if there are any adverse reactions?
- Please include your email address
ALL REQUESTS MUST BE SIGNED BY THE VETERINARIAN AND BE ON LETTERHEADED PAPER
Please allow 3-4 weeks for processing