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.

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.

MrsD, dont know what this mixup is but obviously there is one if the FDA is listing it as such. All I know is that I was prescribed the pill of prostigmin by my neuro at U of Iowa hosptials and my pharmacy here in Iowa at a major grocery chain bought is readily from their US supplier. There I asked today if they could get the injection of prostigmin and they said no not thru their supplier. There have been some drugs they cant get.

I put in a call to FDA. Left a message so should hear soon.

Annie59

I believe you'd get faster service with Valeant's phone line, than the FDA.

It might be that the injection is only available thru hospitals via direct purchase, and or pharmacies supplying nursing homes where nurses administer it.
Technically the major use would be anesthesia support and illeus treatment for complex GI things/surgery. Some drugs are not sold to retail pharmacy outlets for sale to individuals privately.

Yes the FDA has not called back. I am not understanding tho when you say injectible only. I didnt get my pills from an odd source. I have been getting prostimine pills. I get treated at the University of Iowa Hospitals and Clinics. The neuromuscular doc who handles my case and is the doctor over the MDA clinic there prescribed prostigmin for me when I asked.

I will give Valeant another call this week. I did call them but got an automated line this time that wouldnt transfer me. I dug up the number I called last time that worked.

Annie59

Annie59 was prescibed prostigmin here in Iowa on August 2 of this year.

AnnieB3 says Neostigmine Bromide is Prostigmin. And is this what you guys are referring to and Is this another one of those "sound alike" drug things?
Prostigmin -Prostigmine

mrsD says that Neostigmine or Prostigmin is no longer marketed in the United States like it is 2 different drugs.

I am still confused and wondering why this thread seems to have died.

Maybe alice md could jump in back in again.

Tony

The issue remains unresolved as far as I can tell.

According to the FDA website data, this drug is not listed anywhere there. Some websites say it is not available in US, etc.

So its status is unclear. However, obtaining the injection, even if it is now available, say a new development, may be difficult because this drug is very dangerous when injected. The doctor would have to instruct the patient how to do it safely. Not all patients are trustworthy or experienced enough to handle it IMO.

Some drugs are not available thru normal wholesalers, mostly because they are not requested often enough to keep fresh on the shelves. May go out of date before requested. Also it may come in units of 25, like sold to hospitals etc. Hospitals obtain most of their medications directly from manufacturers, because they use odd or rare things, and also to save money.

We'll have to wait for Annie59 and see if she finally obtains it.
Basically it is just not a common drug and has a history of being unavailable in US.

http://www.valeant.com/products/index.jsp shows Prostigminor sale in USA,
Mexico, Canada and Brazil.

Tony

Sorry, I meant Prostigmin at this wedsite.
Tony

I already put that link up earlier in this thread. Post #11.
The PDF listed there is from '06 and does not include the injection. The FDA information is for '08 that I quote, saying no listing for it anymore.

Valeant has not updated that listing since '06.

Annie59 wants the injectable form.