Actavis says an outlier subject triggered FDA’s determination that its Watson Laboratories Inc. subsidiary’s bupropion XL 300 mg is not therapeutically equivalent to GlaxoSmithKline PLC’s antidepressant Wellbutrin XL and that it was not able to rerun the tests because the contract research organization it used went out of business.
Watson’s Bupropion XL Undone By Outlier Patient, Bankrupt CRO
After long delay, FDA quietly reveals second Wellbutrin generic deemed not therapeutically equivalent; ex-Office of Generic Drugs official predicts FDA will tighten criteria for extrapolating data to higher generic strengths.