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Generic Lovenox shows US/EU split on data requirements

This article was originally published in Scrip

Executive Summary

The US approval of Sandoz' generic version of Sanofi-Aventis' antithrombotic Lovenox (enoxaparin sodium) raises a number of questions, not least why the FDA sees the product as a generic while for the European authorities a low molecular weight heparin (LMWH) is a biosimilar drug requiring clinical trials for approval.

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