Budeprion XL bupropion regulatory update

Impax and Teva pulled a generic version of antidepressant Wellbutrin XL bupropion 300 mg from the market after FDA determined the generic is not bioequivalent to the branded product. FDA approved the generic in 2006 based on an extrapolation of bioequivalence data from a 150 mg dose. However, in 2007 the agency received reports of adverse events or lack of efficacy after switching from Wellbutrin to the generic, called Budeprion XL. FDA conducted a trial in 2010 in 24 healthy volunteers showing that Budeprion XL 300 mg tablets do not release bupropion into the blood comparably to Wellbutrin XL 300 mg. ...