Rhone-Poulenc Rorer files Lovenox sNDA; RPR and Pharmacia & Upjohn in LMWH parity indication leap-frog.
Executive Summary
RHONE-POULENC RORER LOVENOX SUPPLEMENTAL NDA FILED Dec. 27 for the low molecular weight heparin injection for prevention of deep vein thrombosis, which may lead to pulmonary embolism in patients undergoing surgery for high-risk abdominal, gynecological or urological conditions. Enoxaparin sodium for injection has been available in the U.S. and Canada since 1993, when it was approved for prevention of DVT following hip or knee replacement. Lovenox is the only LMWH approved for that indication.