Breaking News, Trials & Filings

J&J’s Xarelto Approved by FDA

DVT indication brings Lovenox-buster to U.S. market

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Johnson & Johnson subisidiary Janssen Pharmaceuticals has received FDA approval for Xarelto, a novel, once-daily, oral anticoagulant for the prevention of deep vein thrombosis (DVT), which may lead to a pulmonary embolism (PE) in people undergoing knee or hip replacement surgery. Pivotal data from the Xarelto Phase III clinical development program reflected in the approved label showed significantly greater efficacy of rivaroxaban, both in head-to-head comparison with enoxaparin (Lovenox) a...

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