Teva gains FDA response on generic Lovenox, prompting sharp dive in Momenta shares
This article was originally published in Scrip
Executive Summary
Teva Pharmaceutical Industries reported that the US FDA issued the company a minor deficiency letter regarding its long-pending ANDA application for a generic version of Sanofi-Aventis' blood thinner Lovenox (enoxaparin), but the firm provided very little in the way of disclosure that would allow investors to gauge the chances of the product gaining regulatory approval.