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In Brief: Sanofi Winthrop

Executive Summary

Sanofi Winthrop: Files petition May 18 with FDA for stay of action on pending ANDAs for hydroxychloroquine (Plaquenil) "in the absence of demonstration that assay techniques provide for adequate metabolite separation and absence of co-elution." Sanofi originally made its argument in a Jan. 20 citizen petition ("The Pink Sheet" Feb. 6, T&G-12)...
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