From:
Sukie Crandall
Date: 2010-12-04 23:48:44 UTC
Subject: [ferrethealth] importing Suprelorin to the U.S.
To: fhl <ferrethealth@yahoogroups.com>, Ferret Mailing List <ferret-l@LISTSERV.FERRETMAILINGLIST.ORG>
I am just putting things together once more to help people whose=20
veterinarians need this info, having been asked for it again today so=20
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=20
IS approved by the FDA*. Peptech is working to try to get a future=20
U.S. distribution chain worked out but I am not privy to details.
Originally, there was a miscommunication btwn two branches of the=20
FDA. Neither branch knew that they had miscommunicated, so paperwork=20
sat and sat. One day in a reply from the FDA I got lucky enough that=20
the branch which thought that it was not okay for most to import=20
Suprelorlin copied to the veterinary branch. That was NOT my doing.=20=20
It was just plain, dumb luck, and I guess if someone is going to get=20
lucky that was a good place to get lucky. The person at the=20
veterinary branch then wrote to both that person and me saying pretty=20
much, "Hey, here's the approval record for deslorelin so I don't see=20
the problem." * Then importation got much easier for all. We've all=20
run into miscommunication problems all over the place in the past,=20
including some involving us -- and I did that again yesterday, too,=20
and I know that everyone has been in a similar spot at times, so each=20
of us can see that this sort of thing could also happen in a busy hive=20
of productive professionals. What's important is that they responded=20
so rapidly and constructively as soon as the miscommunication was=20
discovered. Kudos to them for that.
Your vet will write to
Rosie Warren
rwarren@peptech.com
or
Kathy Yeates
kyeates@peptech.com
or for more general information write to
suprelorin@peptech.com
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=20
veterinary hospital letter to
accompany the imported items. Sometimes countries change the=20
numbering systems for permissions and the like, so each time check the=20
letter template they send out since it may have changed.
Yes, they DO provide a template for those hospital letters which will=20
accompany the medications. That gives the designations of various=20
approvals and more. I don't know if they send along the list of=20
current studies though I have sent them the one I put together for my=20
vets.
Here is the vet study info I sent to my vets which was part of their=20
letter. I placed the U.S. studies first because the FDA has at times=20
weighed U.S. studies more highly than non-U.S. ones for some other=20
things (such as its current consideration of sublingual=20
immunotherapy)and I put the newest U.S. article first. More on these=20
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, Pich=E9 CA, J=F6chle W, Oliver JW.
Division of Laboratory Animal Resources, 3500 Terrace St, S1049 BST,
University of Pittsburgh, Pittsburgh, PA 15261, USA.=09
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=20
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.N.J.
5. Vet Rec. 2010 Jan 16;166(3):74-8.
Comparison of four treatments to suppress ovarian activity in ferrets
(Mustela putorius furo).
Proh=E1czik A, Kulcs=E1r M, Trigg T, Driancourt MA, Huszenicza G.
Faculty of Veterinary Science, Szent Istv=E1n University, Istv=E1n utca 2,
1078 Budapest, Hungary.
The implants are large so a bit of Iso to give it and a bit of=20
surgical glue on top can make sense. Not everyone does that, but if I=20
were getting something that size I'd want numbing and some do try to=20
scratch the area which is why our vets put them a bit below a scapula=20
near the spine.
If a ferret needs subcu it needs to be known that this may cause the=20
implant to not last as long but so far no one has mentioned any hazard=20
from that (saying that because we once had to check for the needs of=20
one of our ferrets).
Suprelorein does not work for all but does work for many. It appears=20
that if carcinoma is present it may pay to put in a new implant every=20
6 months.
I have been told of one case where the FDA in California opened and=20
inspected the package and was told that if that happens there is a $50=20
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=3D14
1-044 for the entry in the Animal Drugs @ FDA database.
Sukie (not a vet)
Recommended ferret health links:
http://pets.groups.yahoo.com/group/ferrethealth/
http://ferrethealth.org/archive/
http://www.afip.org/ferrets/index.html
http://www.miamiferret.org/
http://www.ferrethealth.msu.edu/
http://www.ferretcongress.org/
http://www.trifl.org/index.shtml
http://homepage.mac.com/sukie/sukiesferretlinks.html
all ferret topics:
http://listserv.ferretmailinglist.org/archives/ferret-search.html
"All hail the procrastinators for they shall rule the world tomorrow."
(2010, Steve Crandall)
On change for its own sake: "You can go really fast if you just jump=20
off the cliff."
(2010, Steve Crandall)
"Trust, the Final Frontier"
(2010, Juliette Powell)
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