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Subject:
From:
Sukie Crandall <[log in to unmask]>
Date:
Wed, 15 Sep 2010 11:23:25 -0400
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Just seeking because some are doing internet shopping, but internet
shopping for drugs comes complete with numerous horror stories,
cautions, and the related stereotype. (That does not mean that there
are not exceptions from the stories, cautions and stereotype, of
course.)

If the FDA has approved it then my hope would be that would lessen any
possible risk rate.

If the FDA has not approved that specific generic form there might be
even more reason for caution. So I am wondering...

*****I did not have time for a month by month search. Could someone
else who is interested look, please? I have attached two URLs that can
get you started.*****

<http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/DrugandBiologicApprovalReports/ANDAGenericDrugApprovals/default.htm>

>ANDA (Generic) Drug Approvals
>To find all Generic Approvals and Tentative Approvals, you can search
>Drugs@FDA, using the "Drug Approval Reports by Month" feature. On the
>Drug Approval Reports page, select:
>
> -- "Original Abbreviated New Drug Approvals (ANDAs) by Month" for
>Generic Approvals
>-- "Tentative Approvals by Month" for Tentative Approvals New
>approvals and tentative approvals are added to Drugs@FDA Reports on a
>daily basis, so you can run the reports every day to find the latest
>approvals.

<http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Reports.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/2009/019943s029,020011s036lbl.pdf>

This is the approval for the non-generic in 1993:
<http://www.accessdata.fda.gov/scripts/cder/ob/docs/obdetail.cfm?Appl_No=020263&TABLE1=OB_Rx>
so it seems like it has been around for long enough for a generic to be
okayed, too. [I think there many years left more before that. BIG]

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 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= Lupron Injection
> Treatment of central precocious puberty.
> Tap Pharmaceuticals, Inc.
> 2355 Waukegan Road
> Deerfield, IL 60015
> DD=07/25/1988 MA=04/1G/1993

Here's the 2001 approval for the 3 month version of Lupron:
<http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/DrugandBiologicApprovalReports/EfficacySupplementApprovals/ucm081876.htm>

I have NOT been able to find the FDA approval of the generic form of
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)

[Posted in FML 6822]


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