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FDA approval of generic Lovenox sparks debate and lawsuit

This article was originally published in Scrip

Executive Summary

The US FDA approval of the first generic version of Sanofi-Aventis's Lovenox (enoxaparin sodium) to Novartis' generics arm Sandoz, which uses technology from Momenta Pharmaceuticals, has caused a buzz because the agency has treated the application like a standard but yet complicated ANDA and did not require full clinical studies.


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