FDA Approves Novartis's Diovan to Lower Hypertension
Diovan, in both capsule and tablet formulations, has been approved for the treatment of hypertension in adult subjects.
It offers blood pressure control comparable to current leading antihypertensive therapies (lisinopril and enalapril) and an outstanding side effect profile.
As with other drugs that affect the renin-angiotensin system, Diovan can cause fetal and neonatal morbidity and death when administered to pregnant women. Diovan therapy should be discontinued as soon as pregnancy is detected.
Hypertension, the term used for abnormally high blood pressure, is the most common health problem in the United States. Over 50 million Americans suffer from hypertension, but many are unaware of the problem and remain untreated. Left untreated, it can lead to serious and life-threatening events including stroke and heart attack
Diovan has been approved as the newest entry to a novel class of antihypertensive drugs, the angiotensin II receptor blockers (ARBs). Diovan is indicated for the first-line treatment of hypertension. It offers blood pressure control comparable to current leading antihypertensive therapies (lisinopril and enalapril) and an outstanding side-effect profile.
Diovan is a first-line therapy, which has a recommended starting dose of 80 mg once daily and will be available by prescription in capsule form.
As with other drugs that work in the renin-angiotensin system, Diovan therapy should be discontinued as soon as pregnancy is detected.
"Novartis believes it is important to provide physicians with treatment options such as Diovan which are effective in treating high blood pressure in this vulnerable population of children and adolescents," said John Orloff, MD, Senior Vice President, Medical and Drug Regulatory Affairs, Novartis Pharmaceuticals Corporation.