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FDA Grants New Indication For Pfizer/Bristol Anticoagulant
The FDA has approved a new indication for apixaban (Eliquis), the anticoagulant drug manufactured by Bristol-Myers Squibb and Pfizer. The new indication is for the prophylaxis of deep vein thrombosis (DVT) in patients who have undergone hip or knee replacement surgery. DVT can lead to the life-threatening condition of pulmonary embolism (PE). The DVT prophylaxis indication joins the previously approved indication of stroke prevention in patients who have nonvalvular atrial fibrillation.
Source: Forbes.com Healthcare News - March 14, 2014 Category: Pharmaceuticals Authors: Larry Husten Source Type: news

FDA Once Again Rejects New Indication For Johnson & Johnson's Xarelto
The third time wasn't the charm. The FDA today turned turned down-- for the third time-- the supplemental New Drug Application (sNDA) for rivaroxaban (Xarelto, Johnson & Johnson) for use in acute coronary syndrome patients to reduce MI, stroke or death. In addition, the FDA-- for the second time-- turned down the sNDA for rivaroxaban in the same population for the reduction of stent thrombosis.
Source: Forbes.com Healthcare News - February 14, 2014 Category: Pharmaceuticals Authors: Larry Husten Source Type: news

New Trial Confirms Role For Pradaxa In Venous Thromboembolism
A new study helps support a role for  the new oral anticoagulant dabigatran (Pradaxa, Boehringer Ingelheim) in patients with venous thrombosis (VTE).  The RE-COVER II trial, published online in Circulation, confirms the finding of the earlier and highly similar RE-COVER trial, published in the New England Journal of Medicine in 2009, that dabigatran is as safe and effective as warfarin for the treatment of  deep vein thrombosis (DVT) and pulmonary embolism (PE). Dabigatran is currently approved only for the treatment of stroke prevention in patients with non-valvular atrial fibrillation.
Source: Forbes.com Healthcare News - December 18, 2013 Category: Pharmaceuticals Authors: Larry Husten Source Type: news