Company Product Description Indication Status
Correvio Pharma Corp., of Vancouver, British Columbia Brinavess Vernakalant I.V. Atrial fibrillation  Received complete response letter from FDA on NDA; FDA indicated that Correvio will need to develop an approach to select patients who are at low risk of adverse cardiovascular reactions and data from an additional study will be needed to assess CV risk and to support an NDA resubmission; FDA also stated risk of serious cardiovascular adverse reactions will need to be much less than 1% in selected patient population
Micro Labs Ltd., of Bengaluru, India, and Mylan Pharmaceuticals Inc., of Canonsburg, Pa. Eliquis Apixaban Stroke FDA granted approval of generic apixaban applications


For more information about individual companies and/or products, see Cortellis.

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