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?
poster:andrewb
thread:21185
URL: http://www.dr-bob.org/babble/20000209/msgs/21218.html