Trials & Filings

FDA Accepts Eliquis sNDA

BMS, Pfizer seek new indications against DVT, PE

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

The FDA has accepted for review an sNDA for Eliquis (apixaban) for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and for the reduction in the risk of recurrent DVT and PE. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is August 25, 2014, according to the drug’s developers, Bristol-Myers Squibb and Pfizer. The sNDA submission is supported by results from two Phase III trials, AMPLIFY and AMPLIFY-EXT, which were both originally pub...

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