Janssen announced that the FDA has approved Xarelto (rivaroxaban), an oral anticoagulant, for the treatment of deep vein thrombosis (DVT) and/or pulmonary embolism (PE), and to reduce the risk of recurrence of DVT and PE following initial treatment.
The FDA has approved the supplemental New Drug Application for Xarelto (rivaroxaban; Janssen) to include updated information for patients with prosthetic heart valves.
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.
The summary below gives an overview of important additions and changes MPR has made to its drug database through the end of November. The chart below provides highlights of key monograph updates made this month (not an inclusive list). Click on the name of the drugs to view the full monographs on eMPR.com. Key: D=Dosing,…
The summary below gives an overview of important additions and changes MPR has made to its drug database through the end of December. The chart below provides highlights of key monograph updates made this month (not an inclusive list). Click on the name of the drugs to view the full monographs on eMPR.com. Key: D=Dosing,…
The new sNDA submission is supported by the 'Einstein Choice' study, which included 3,365 patients in a Phase 3 randomized, double-blind study that compared Xarelto once daily to aspirin.
The summary below gives an overview of important additions and changes MPR has made to its drug database through the end of November. The chart below provides highlights of key monograph updates made this month (not an inclusive list). Click on the name of the drugs to view the full monographs on eMPR.com. Key: D=Dosing,…
The summary below gives an overview of some of the important additions and changes MPR has made to its drug database through the end of December. The chart below provides highlights of the 118 key monograph updates made this month (not an inclusive list).
