FDA Advisory Committee Votes Down Actavis’ Anti-hypertensive Combination Therapy
Actavis plc report that the
â€‹The committee recommendation is not binding on the
â€‹Nebivolol/valsartan (5/80 mg, 5/160 mg, 10/160 mg, 10/320 mg, and 20/320 mg) is an investigational fixed-dose combination. It combines two
Nebivolol (marketed in the US as Bystolic by Actavis through its subsidiary Forest Laboratories) is indicated for the treatment of hypertension and is effective at lowering blood pressure when taken alone or in combination with other antihypertensive agents, such as angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor blockers (ARBs), and/or diuretics. Valsartan is a well-established ARB, It is the active ingredient in Novartis’ Diovan, and it is also off-patent and provided by generic-drug manufacturers.