From:
Sukie Crandall
Date: 2010-09-15 15:10:35 UTC
Subject: [ferrethealth] Any FDA okayed Leuprolide Acetate depot AS THE GENERIC?
To: fhl <ferrethealth@yahoogroups.com>
Just seeking because some are doing internet shopping, but internet=20
shopping for drugs comes complete with numerous horror stories,=20
cautions, and the related stereotype. (That does not mean that there=20
are not exceptions from the stories, cautions and stereotype, of=20
course.)
If the FDA has not approved that specific generic form there might be=20
even more reason for caution, so I am wondering.
I did not have time for a month by month search.
<http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedan=
dApproved/DrugandBiologicApprovalReports/ANDAGenericDrugApprovals/default.h=
tm
>
> ANDA (Generic) Drug Approvals
> To find all Generic Approvals and Tentative Approvals, you can=20
> search Drugs@FDA, using the "Drug Approval Reports by Month"=20
> feature. On the Drug Approval Reports page, select:
>
> =95 "Original Abbreviated New Drug Approvals (ANDAs) by Month" for=20
> Generic Approvals
> =95 "Tentative Approvals by Month" for Tentative Approvals
> New approvals and tentative approvals are added to Drugs@FDA Reports=20
> on a daily basis, so you can run the reports every day to find the=20
> latest approvals.
>
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=
=3DReports.ReportsMenu
Safety labeling changes in April:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm212105.htm
and June 2009
http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm169690.htm
official description:
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019943s029,020011s=
036lbl.pdf
This is the approval for the non-generic in 1993:
http://www.accessdata.fda.gov/scripts/cder/ob/docs/obdetail.cfm?Appl_No=3D0=
20263&TABLE1=3DOB_Rx
so it seems like it has been around for long enough for a generic to=20
be okayed, too.
I'll add a search term and do
Leuprolide Acetate depot approval
because I do NOT have time for a month by month search
http://www.fda.gov/Drugs/NewsEvents/UCM130961
August 31 this year:
> Lupron Depot-Ped (leuprolide acetate) Injection, Abbott=20
> Laboratories, Labeling Revision
in
> New and Generic Drug Approvals
> Visit Drugs@FDA to search Drug Approval Reports by Month.
>
gives the feeling that it HAS been okayed for sale as a generic.
Here was its addition to the orphan products list in 1999 as Lupron:
http://www.fda.gov/ohrms/dockets/dailys/00/mar00/030100/lst0094.pdf
> Leuprolide acetate
> TN=3D Lupron Injection
> Treatment of central precocious puberty.
> Tap Pharmaceuticals,
> Inc.
> 2355 Waukegan Road
> Deerfield, IL 60015
> DD=3D07/25/1988 MA=3D04/1G/1993
>
Here's the 2001 approval for the 3 month version of Lupron:
> http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopeda=
ndApproved/DrugandBiologicApprovalReports/EfficacySupplementApprovals/ucm08=
1876.htm
I have NOT been able to find the FDA approval of the generic form of=20
the depot but I have not looked closely.
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)
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