Upsher-Smith Generic Amiodarone BioStudy Dose Challenged by Wyeth
Executive Summary
Bioequivalence studies conducted by Upsher-Smith for the ANDA approval of its generic amiodarone Pacerone are insufficient to show therapeutic equivalence to Wyeth-Ayerst's antiarrhythmic drug Cordarone because subjects were not exposed to adequate levels of the drug, Wyeth maintained in a July 17 citizen petition.