Teva´s wellbutrin XL pulled from the Market // IGXTs forfivo which launched in Oct will be a big Winner !!!
I love all the big news for this tiny and huge underpriced company .
Teva pulled it's Wellrutrin XL because it didn't work as well as brand name. They launch their's in 2007 and FDA looked into effectiveness of the drug and found it not working and pulled it today. FDA changed their rules last year to test the maximum strength of generics. Forfivo was approved in November last year at the 450 max dose. So IGXT is ok and has an even bigger market opportunity. Here is an exerpt from article.
The FDA initially required companies to study generic versions of Wellbutrin XL only in the 150-mg dose and allowed them to extrapolate the results to the 300-mg dose because of concerns with seizure risk, Barbara Davit, director of the division of bioequivalence II in the Office of Generic Drugs, said yesterday during a conference call. The agency will now require testing on the highest available strength, she said.