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.
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After agency tightened bioequivalence testing recommendations for tacrolimus products post approval, studies found Accord’s generic version of Prograf may deliver higher concentrations, leading agency to downgrade its therapeutic equivalence rating. No problems were found with five other tacrolimus ANDAs.
Mallinckrodt and Kremers seem prepared to fight formal notice, which comes almost two years after FDA found their methylphenidate generics failed to demonstrate bioequivalence to the Janssen's brand drug.
Data integrity spotlight expands beyond cGMP as FDA finds Semler manipulated study subject samples in bioequivalence studies conducted at its Bangalore facility.