Amphastar Lawsuit Over Heparin Shipments Suggests Lovenox ANDA Approval May Be Far Off
Executive Summary
Allegations in Amphastar Pharmaceuticals’ lawsuit over FDA detention of heparin raw ingredient shipments suggest approval of its enoxaparin ANDA, the generic of Sanofi-Aventis’ low-molecular weight heparin Lovenox, is far from imminent.
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