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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.
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PS032607

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