![[dr. bob]](/dr-bob-sm.gif)
Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 8 of 8. This is the beginning of the thread.
Posted by Abby on February 11, 2000, at 18:45:32
Andrew was kind enough to send me information on
amisulpride. I started looking over some abstracts on
amisulpride, and it seemed (in schizophrenia) to be
equal to,and in some ways superior to risperidone.So, I wondered why it isn't available over here. Was
it that the FDA process was too cumbersome and
expensive? Was it rejected? If so, why? How do you
find this kind of information? Is there an on-line
source which provides the names of medications and who
manufactures/holds the patent on them?Does anyone know who makes amisulpride? What about
seroquel? How do you find out?Phil--How did you get the FDA info. on reboxetine?
Abby
Posted by Phil on February 11, 2000, at 19:01:16
In reply to amisulpride and general FDA question, posted by Abby on February 11, 2000, at 18:45:32
Abby,
I just called them at (888)463-6332 and asked.
Phil
Posted by andrewb on February 11, 2000, at 22:10:55
In reply to amisulpride and general FDA question, posted by Abby on February 11, 2000, at 18:45:32
Amisulpride was developed and is marketed by Synthlabo, a French company I believe. It was first marketed in Portugal in '86 and has since been marketed over much of Europe and some other countries like Brazil and Argentina. They have never tried to get it apporved in the U.S.
I'd be in interested in knowing why certain European drug companies seek FDA approval for US marketing at times for their drugs and at other times they don't. Also, why is it so hard for a drug like Reboxetine to get US approval?
Posted by torchgrl on February 11, 2000, at 23:56:29
In reply to Re: amisulpride , posted by andrewb on February 11, 2000, at 22:10:55
I think part of it is that the American FDA is more stringent in their requirements before approving drugs. I know that with Reboxetine, they wanted to have studies done domestically, despite the results available from abroad, hence my opportunity to take it briefly through a study. It also seems to be more expensive to get anything done here, although that may just be my perception.
Posted by JohnL on February 12, 2000, at 4:40:27
In reply to amisulpride and general FDA question, posted by Abby on February 11, 2000, at 18:45:32
FDA approval is a long and expensive process, involving millions of dollars. In the end, if the drug for some reason isn't approved, the company has lost millions of dollars on a failed mission. For example if Reboxetine is not approved, imagine how much time and money was lost in the effort. And in that case of Reboxetine, the failed approval would be based on certain wording on the insert? Ouch. That's a huge expense and a risk not all are willing to take. I suspect the pharmaceutical company that makes Solian (Amisulpride) is too small a player to afford the expense or the risk. They have their drug approved in other parts of the world where there aren't so many expensive roadblocks. In addition, my pdoc told me that the USA is hindered by excessive litigation. Too many greedy victims (some legit, some not) hiring greedy lawyers. Too much litigation. This is yet another roadblock that causes pharmaceutical companies to hesitate. It's too bad, because Solian is a wonderful drug with few side effects.
But for anyone interested, it is available legally even in the absence of FDA approval. A Swiss pharmacy can mailorder it with a valid prescription. I know of several neighboring European pharmacies that can mailorder it to your door in ten days with a valid (or even not so valid) faxed prescription. On the green customs label on the shipping box it will say 'prescriptin medicine for personal use, prescription included'. Sure enough, a copy of the faxed prescription is inside the box for customs to see if they so desire. No prob.
Posted by jacquie on December 5, 2000, at 19:40:40
In reply to Re: amisulpride and general FDA question, posted by JohnL on February 12, 2000, at 4:40:27
> FDA approval is a long and expensive process, involving millions of dollars. In the end, if the drug for some reason isn't approved, the company has lost millions of dollars on a failed mission. For example if Reboxetine is not approved, imagine how much time and money was lost in the effort. And in that case of Reboxetine, the failed approval would be based on certain wording on the insert? Ouch. That's a huge expense and a risk not all are willing to take. I suspect the pharmaceutical company that makes Solian (Amisulpride) is too small a player to afford the expense or the risk. They have their drug approved in other parts of the world where there aren't so many expensive roadblocks. In addition, my pdoc told me that the USA is hindered by excessive litigation. Too many greedy victims (some legit, some not) hiring greedy lawyers. Too much litigation. This is yet another roadblock that causes pharmaceutical companies to hesitate. It's too bad, because Solian is a wonderful drug with few side effects.
>
> But for anyone interested, it is available legally even in the absence of FDA approval. A Swiss pharmacy can mailorder it with a valid prescription. I know of several neighboring European pharmacies that can mailorder it to your door in ten days with a valid (or even not so valid) faxed prescription. On the green customs label on the shipping box it will say 'prescriptin medicine for personal use, prescription included'. Sure enough, a copy of the faxed prescription is inside the box for customs to see if they so desire. No prob.JohnL- What are the "few side effects" of amisulpride and what is rec.dosage for depression? i see alot of 25mg to 50 mg. any advice?
Posted by JohnL on December 6, 2000, at 3:43:54
In reply to Re: amisulpride and general FDA question, posted by jacquie on December 5, 2000, at 19:40:40
> JohnL- What are the "few side effects" of amisulpride and what is rec.dosage for depression? i see alot of 25mg to 50 mg. any advice?Hi Jacquie,
The only primary side effect I've noticed is mild sleep disturbance. Other than that, none. I have heard of one person who experienced some anxiety side effects. At the low doses used for depression (25mg to 100mg), Amisulpride is nearly, or even completely, side effect free. At very high doses used for psychosis (400mg to 1200mg), I believe its side effects are similar to other antipsychotics.
John
Posted by JohnL on December 6, 2000, at 3:44:25
In reply to Re: amisulpride and general FDA question, posted by jacquie on December 5, 2000, at 19:40:40
> JohnL- What are the "few side effects" of amisulpride and what is rec.dosage for depression? i see alot of 25mg to 50 mg. any advice?Hi Jacquie,
The only primary side effect I've noticed is mild sleep disturbance. Other than that, none. I have heard of one person who experienced some anxiety side effects. At the low doses used for depression (25mg to 100mg), Amisulpride is nearly, or even completely, side effect free. At very high doses used for psychosis (400mg to 1200mg), I believe its side effects are similar to other antipsychotics.
John
This is the end of the thread.
Psycho-Babble Medication | Extras | FAQ
Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.org
Script revised: February 4, 2008
URL: http://www.dr-bob.org/cgi-bin/pb/mget.pl
Copyright 2006-17 Robert Hsiung.
Owned and operated by Dr. Bob LLC and not the University of Chicago.