Novartis has received final approval for its combination product, Exforge, used to treat hypertension.
Novartis has received final approval for its combination product, Exforge, used to treat hypertension. According to the company, it is the first medication to combine an angiotensin receptor blocker (valsartan [Diovan]) and a calcium-channel blocker (amlodipine [Norvasc]) into a tablet taken once daily. Exforge was studied in two clinical trials in which nine out of 10 patients reached their treatment goal of diastolic blood pressure less than 90 mmHg or more than a 10 mmHg reduction in diastolic BP from baseline levels. Exforge is not meant as an initial treatment for blood pressure and should be used only in patients who have not been controlled through the use of any type of medicine in the angiotensin receptor blocker or calcium-channel blocker classes.
FDA Issues CRL for Heplisav-B in Adults With ESRD on Hemodialyis
May 14th 2024Dynavax plans to meet with the FDA to discuss how the company can provide additional data to support the approval of its 4-dose Heplisav-B regimen and expand protection for adults with end-stage renal disease (ESRD) on hemodialysis.