I am sure they make it, but according to the FDA and their lists, it is not available in US anymore.
There are many things slipping thru the FDA cracks these days.
Valeant may be selling it to other countries. I put up the list of other countries where it is available.
The FDA just put a stop in '09 to cough syrups with hydrocodone in them, which did not have FDA approval and were sold here in US commonly. Neostigmine has been around since 1939 in US, and all the old drugs grandfathered into the FDA which came much later, are being requested to have new drug applications made with studies to continue to be sold here. The PDF I found at FDA.gov which you can find too by searching Prostigmin...says clearly not available here as of 2008. It does not appear in the Orange book either, which is updated monthly.
Quote:
Page 1
Food and Drug Administration
Center for Drug Evaluation and Research
Meeting of the Gastrointestinal Drugs Advisory Committee (GIDAC)
To Evaluate Entereg (Alvimopan) for the Acceleration of Recovery Time to Upper
and Lower Gastrointestinal Recovery Following Partial Large or Small Bowel
Resection Surgery with Primary Anastomosis
January 23, 2008
Neostigmine (ProstigminŽ), a parasympathomimetic agent, was approved by the FDA in
1939 for the treatment or prevention of post-operative non-obstructive abdominal distention
(adynamic ileus). Currently, this drug product is no longer listed in the orange book and is
not marketed in the United States.
|
This is the only entry for Prostigmin in FDA search base that I could find.
I find this puzzling, and if you talk to Valeant again, ask for details. Should you have a "problem" using this injection, and it is not approved here, there will be no way to attach further liability for either contamination or poor manufacturing reasons.
If you go to Valeant's website for US you will not find it there either. Here is their Neurology page:
http://www.valeant.com/products/neurology/index.jsp
There is a PDF here at this link:
http://www.valeant.com/products/index.jsp
from 06.... no injection. Since FDA is from '08 that is more recent information.
So get that clarification. Just to be sure. See if they will send you information via email, etc. And then put it up here if possible. Many companies will do that, and I have done it in the past.
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All truths are easy to understand once they are discovered; the point is to discover them.-- Galileo Galilei
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Weezie looking at petunias 8.25.2017
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