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.
You may also be interested in...
Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials
Shire Hopes To Sow Future Deals With $50M Venture Fund
Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth