Posted by seldomseen on February 26, 2009, at 7:15:04
In reply to Any problems with Generic Lamictal?, posted by JayBTV2 on February 25, 2009, at 11:25:06
Well, the term "bioequivalent", according to the FDA, means that the manufacturer of the generic drug has to be 90% confident that maximal plasma concentration of the drug/active metabolites *AND* the area under the plasma absorption/distribution curve is between 80-120% of the name brand.
This "wobble" is why drugs with a narrow therapeutic range can not be substituted with generic. There can be some differences between generic and name brand. Are these differences clincially significant for a drug like lamictal? Well, everyone is different.
What worries me the most is when pharmacies switch generic manufacturers. I don't think the FDA mandates that the generics demonstrate equivalence to each other, just to the name brand (does anyone know???).
In that instance there could up to a 40% difference between the two generics. Kinda scary.
Seldom
poster:seldomseen
thread:882387
URL: http://www.dr-bob.org/babble/20090223/msgs/882575.html