It's not that the implants have not been approved for the U.S. but that
there is not yet a distributor here.

For a while there was an approval disagreement. Deslorelin itself had
been approved but the implant's delivery system had not been. So, one
branch of the FDA figured it was okay and another did not; the trick
was getting those two branches talking with each other (which happened
to me by ***total accident*** when I was discussing the implant in
detail with someone in the branch which thought it was not okayed who
then contacted someone in the veterinary branch and worked me into the
conversation because some of my details made them think maybe a mix-up
had happened -- as it had. So, I just had plain dumb luck that week,
nothing more.)

This will help your vet with the importation:
http://ferrethealth.org/archive/FHL12551

>Date: Sat, 04 Dec 2010 18:48:44 -0500
>To: FML, FML
>Subject: [ferrethealth] importing Suprelorin to the U.S.
> 
>I am just putting things together once more to help people whose
>veterinarians need this info, having been asked for it again today so
>this is revised for general use and has some added information.
>
>The implants are not DISTRIBUTED in the U.S. but deslorelin as a drug
>IS approved by the FDA*. Peptech is working to try to get a future
>U.S. distribution chain worked out but I am not privy to details.
>
>Originally, there was a miscommunication btwn two branches of the FDA.
>Neither branch knew that they had miscommunicated, so paperwork sat
>and sat. One day in a reply from the FDA I got lucky enough that the
>branch which thought that it was not okay for most to import
>Suprelorlin copied to the veterinary branch. That was NOT my doing.
>It was just plain, dumb luck, and I guess if someone is going to get
>lucky that was a good place to get lucky. The person at the veterinary
>branch then wrote to both that person and me saying pretty much, "Hey,
>here's the approval record for deslorelin so I don't see the problem."
>* Then importation got much easier for all. We've all run into
>miscommunication problems all over the place in the past, including
>some involving us -- and I did that again yesterday, too, and I know
>that everyone has been in a similar spot at times, so each of us can
>see that this sort of thing could also happen in a busy hive of
>productive professionals. What's important is that they responded so
>rapidly and constructively as soon as the miscommunication was
>discovered. Kudos to them for that.
>
>Your vet will write to
> Rosie Warren
> [log in to unmask]
>or
> Kathy Yeates
> [log in to unmask]
>or for more general information write to
> [log in to unmask]
>or see
> http://www.peptech.com/HTML/Animal_Health/Animal_Health.html
>noting that the dog products have been used in ferrets.
>and ask for ordering information for the U.S.
>
>Peptech takes care of almost everything except for parts of the
>veterinary hospital letter to accompany the imported items. Sometimes
>countries change the numbering systems for permissions and the like,
>so each time check the letter template they send out since it may have
>changed.
>
>Yes, they DO provide a template for those hospital letters which will
>accompany the medications. That gives the designations of various
>approvals and more. I don't know if they send along the list of
>current studies though I have sent them the one I put together for
>my vets.
>
>Here is the vet study info I sent to my vets which was part of their
>letter. I placed the U.S. studies first because the FDA has at times
>weighed U.S. studies more highly than non-U.S. ones for some other
>things (such as its current consideration of sublingual immunotherapy)
>and I put the newest U.S. article first. More on these can be found in
>the Pub Med listings of studies:
> http://www.ncbi.nlm.nih.gov/sites/entrez
> 
>References regarding use of this product in ferrets include:
>1. Vet Clin North Am Exot Anim Pract. 2010 Sep;13(3):439-52.
>Advanced diagnostic approaches and current medical management of
>insulinomas and adrenocortical disease in ferrets (Mustela putorius
>furo).
>Chen S.
>Gulf Coast Avian & Exotics, Gulf Coast Veterinary Specialists, 1111
>West Loop South, Suite 110, Houston, TX 77027, USA.
>
>2. Am J Vet Res. 2005 May;66(5):910-4.
>Clinical and endocrine responses to treatment with deslorelin acetate
>implants in ferrets with adrenocortical disease.
>Wagner RA, Piche CA, Jochle W, Oliver JW.
>Division of Laboratory Animal Resources, 3500 Terrace St, S1049 BST,
>University of Pittsburgh, Pittsburgh, PA 15261, USA.

>3. Domest Anim Endocrinol. 2008 Apr;34(3):278-83. Epub 2007 Sep 10.
>Luteinizing hormone-dependent Cushing's syndrome in a pet ferret
>(Mustela putorius furo).
>Schoemaker NJ, Kuijten AM, Galac S.
>Division of Avian and Exotic Animal Medicine of the Department of
>Clinical Sciences of Companion Animals, Faculty of Veterinary
>Medicine, Utrecht University, Yalelaan 108, 3584 CM Utrecht, The
>Netherlands.

>4. Theriogenology. 2008 Jul 15;70(2):161-7. Epub 2008 Apr 25.
>Use of a gonadotropin releasing hormone agonist implant as an
>alternative for surgical castration in male ferrets (Mustela putorius
>furo).
>Schoemaker NJ, van Deijk R, Muijlaert B, Kik MJ, Kuijten AM, de Jong
>FH, Trigg TE, Kruitwagen CL, Mol JA.
>Department of Clinical Sciences of Companion Animals, Faculty of
>Veterinary Medicine, Utrecht University, The Netherlands.

>5. Vet Rec. 2010 Jan 16;166(3):74-8.
>Comparison of four treatments to suppress ovarian activity in ferrets
>(Mustela putorius furo).
>Prohaczik A, Kulcsar M, Trigg T, Driancourt MA, Huszenicza G.
>Faculty of Veterinary Science, Szent István University, Istvan utca 2,
>1078 Budapest, Hungary.
>
>The implants are large so a bit of Iso to give it and a bit of
>surgical glue on top can make sense. Not everyone does that, but if I
>were getting something that size I'd want numbing and some do try to
>scratch the area which is why our vets put them a bit below a scapula
>near the spine.
> 
>If a ferret needs subcu it needs to be known that this may cause the
>implant to not last as long but so far no one has mentioned any hazard
>from that (saying that because we once had to check for the needs of
>one of our ferrets).
>
>Suprelorein does not work for all but does work for many. It appears
>that if carcinoma is present it may pay to put in a new implant every
>6 months. [Later note: some ferrets may need more med than the smaller
>implant gives so the larger one or two small ones at once can be used]
> 
>I have been told of one case where the FDA in California opened and
>inspected the package and was told that if that happens there is a $50
>repackaging fee. So, just an FYI on that.
>
>*This is the original FDA approval for deslorelin as a drug:
>NADA 141-044 original approval
>Sponsor: Peptech Animal Health Pty, Limited
>Generic Name: Deslorelin Acetate
>Trade Name: Ovuplant (tm)
>Indications for Use: For inducing ovulation within 48 hours in estrous
>mares with an ovarian follicle greater than 30 mm in diameter.
>Date of Approval: June 18, 1998
> 
>Please see
> http://www.accessdata.fda.gov/scripts/animaldrugsatfda/details.cfm?dn=141-044
>for the entry in the Animal Drugs @ FDA database.

[Posted in FML 7076]