FDA approved Trilostane?

[Eskimo'sMom]

I understand that Trilostane in NOT FDA approved. What exactly does this mean? That the FDA does not back up the product? In so , why not? It is a bit scarry for me to consider giving this med to Eskimo if it is no FDA approved. I have yet to treat Eskimo . It has been one week since she was diagnosed. Her Dr is out of town.

[Squirt's Mom]

http://www.compliancehome.com/news/FDA/14174.html


Lysodren is not approved for veterinary use in the USA but it has been and continues to be used successfully regardless just as Trilo did before it was approved.

[Harley PoMMom]

Trilostane is the compounded version of Vetoryl. Vetoryl is FDA approved.

I believe one should purchase the Trilostane from a reputable compounding pharmacy, which the members who do treat with Trilostane can share with you.

[labblab]

Just to clarify even a bit more... "Trilostane" is the chemical name for a drug used to treat canine Cushing's. Worldwide, there is only one brandname version of the drug, and that is "Vetoryl." Vetoryl is marketed by a U.K. company named Dechra. Dechra now also maintains a U.S. office in Kansas. Brandname Vetoryl has received FDA approval for veterinary treatment. There is currently no generic form of Vetoryl available for sale. So the brandname product is the only one which carries FDA approval.

Prior to the FDA's approval of Vetoryl, various compounding pharmacies in the U.S. started preparing and selling their own in-house products containing the active ingredient, trilostane. Many are continuing to sell their own compounded trilostane, but not in the dosage strenths in which Vetoryl is sold (10 mg., 30 mg., 60 mg. capsules). Compounded versions of trilostane are not FDA approved because they have not been produced by pharmaceutical manufacturers pursuant to FDA oversight and regulation. Compounding pharmacies are subject to state licensing boards.

There are some pending complicated legal issues regarding compounded versions of FDA approved drugs. Some vets and owners feel comfortable using compounded versions, and some do not. Here is a link to a post on our "Resources" forum that provides some in-depth discussion of the related issues:

http://www.k9cushings.com/forum/showthread.php?p=1254#post1254

Marianne

[labblab]

Also, here's a link to another member's thread in which the question of using compounded trilostane vs. brandname Vetoryl has been discussed:

http://www.k9cushings.com/forum/showthread.php?t=2620

Marianne