Amphastar lashes out against FDA for stalled generic Lovenox ANDA, seeks court-ordered approval
This article was originally published in Scrip
Executive Summary
Amphastar Pharmaceuticals has filed in the US District Court for the District of Columbia an amended complaint seeking declaratory judgment and injunctive relief requiring the US FDA to cease its unlawful treatment of the company and to approve its long-pending ANDA for a generic version of Sanofi-Aventis's anticoagulant drug Lovenox (enoxaparin sodium).