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Sanofi-Aventis files a new motion challenging generic Lovenox approval

This article was originally published in Scrip

Executive Summary

Sanofi-Aventis has filed a new motion as it continues in its efforts to reverse the US FDA's 23 July approval of a generic version of Lovenox (enoxaparin sodium) by pharmaceutical rival Sandoz ( Novartis) and its partner Momenta. Of significance in its latest motion is the fact that Sanofi makes certain allegations about a disagreement within the FDA on whether one could come to a reasonable assurance of sameness between generic enoxaparin and the reference product Lovenox.


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