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Your search for apixaban returned 17 results

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FDA Wants More Data for Anticoagulant Antidote AndexXa

The FDA has issued a Complete Response Letter (CRL) to the Biologics License Application (BLA) of AndexXa (andexanet alfa; Portola) as a reversal agent for life-threatening or uncontrolled bleeding due to Factor Xa inhibitors.
Drugs in the Pipeline

Reversal Agent for Factor Xa Inhibitors Under FDA Review

Portola Pharmaceuticals announced the submission of a Biologics License Application (BLA) to the Food and Drug Administration (FDA) for its investigational agent andexanet alfa, as a universal reversal agent for patients anticoagulated with an oral or injectable Factor Xa inhibitor who experience a serious uncontrolled bleeding event or who require urgent or emergency surgery. There is currently no…
Drugs in the Pipeline

FDA to Review New Warfarin Formulation

Accu-Break Pharmaceuticals (ABP) announced that the Food & Drug Administration (FDA) has accepted for filling the New Drug Application (NDA) for Warfarin Potassium.
Drugs in the Pipeline

Eliquis Reversal Agent Demonstrates Efficacy in Phase 3 Study

Portola Pharmaceuticals, Bristol-Myers Squibb Company, and Pfizer announced results from the Phase 3 ANNEXA-A (Andexanet Alfa a Novel Antidote to the Anticoagulant Effects of FXa Inhibitors - Apixaban) study with andexanet alfa as a reversal agent for Eliquis (apixaban).
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Results Announced for Eliquis in Nonvalvular Atrial Fibrillation Trial

Bristol-Myers Squibb and Pfizer announced results of a pre-specified subanalysis of the Phase 3 ARISTOTLE trial that assessed the effect of blood pressure control on outcomes as well as the treatment effect of Eliquis (apixaban) vs. warfarin to blood pressure control in patients with nonvalvular atrial fibrillation (NVAF).
Drugs in the Pipeline

FDA to Review Eliquis sNDA for DVT/PE Treatment

The FDA has accepted for review a Supplemental New Drug Application (sNDA) for Eliquis (apixaban; Bristol-Myers Squibb Company and Pfizer) for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and for the reduction in the risk of recurrent DVT and PE.
Drugs in the Pipeline

Eliquis sNDA Accepted for Review for DVT Prophylaxis

The FDA has accepted Bristol-Myers Squibb's and Pfizer's supplemental New Drug Application for Eliquis (apixaban), an oral direct Factor Xa inhibitor for prophylaxis of deep vein thrombosis (DVT) following hip or knee replacement surgery.