Study Reveals Previously Unknown Drug-Associated Arrhythmias
To identify medications with potential proarrhythmic association.
Cardiology
Verquvo Approved for Heart Failure with Reduced Ejection Fraction
The approval was based on data from the double-blind, placebo-controlled phase 3 VICTORIA trial.
Dapagliflozin Under Review for Chronic Kidney Disease
The FDA has granted Priority Review to dapagliflozin (Farxiga) for the treatment of new or worsening CKD.
Decision on Furoscix Delayed Due to Inspection Requirements
Furoscix is a pH-neutral formulation of furosemide designed for SC administration via a wearable, preprogrammed on-body drug delivery system.
Brilinta Approved to Reduce Risk of Recurrent Stroke in High-Risk Patients
The approval was based on data from the phase 3 THALES trial (N=11,016) that compared treatment with ticagrelor plus aspirin to aspirin alone in preventing new stroke events.
Dapagliflozin Gets Breakthrough Therapy Status for CKD Indication
The designation was granted based on results from the phase 3 DAPA-CKD trial, which was stopped early due to “overwhelming efficacy”.
AHA Issues Statement on Drug-Induced Arrhythmias
The objective of the statement was to review and discuss medications that may cause or exacerbate arrhythmias.
Risk of Cardiac Events With Azithromycin, Amoxicillin Compared
The aim of the study was to use real-world data to compare the risk of cardiac events in new users of azithromycin vs amoxicillin.
Confirmatory Testing No Longer Needed for 23andMe’s CYP2C19 Report
The 510(k) clearance allows for modification of the labeling of the previously authorized pharmacogenetics report.
Gadavist Imaging Bulk Package Approved for Multi-Patient Dosing
Gadavist® Imaging Bulk Package is supplied as 604.72mg/mL of gadobutrol in 30mL and 65mL multidose containers.
