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ARTICLE | Company News

FDA reviewing sNDA for Boehringer's Pradaxa

August 29, 2013 12:33 AM UTC

FDA accepted for review an sNDA from Boehringer Ingelheim GmbH (Ingelheim, Germany) seeking to expand the use of Pradaxa dabigatran etexilate to include the acute treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and reduction in risk of recurrence of DVT and PE. The PDUFA date is not disclosed. In July, Boehringer submitted an application to EMA to expand the use of the direct oral thrombin inhibitor to include treatment of acute DVT and PE and the prevention of recurrent DVT and PE. ...