Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.The FDA has approved another new indication for Merck & Co's antihypertensive Hyzaar, making it the first fixed-dose oral combination hypertension drug to help prevent stroke in patients with hypertension and left ventricular hypertrophy.
Subscribe to our email newsletter
Although this approval is good news for Merck, and for many patients, the new stroke risk indication is based on the landmark LIFE trial, which indicated that this benefit does not apply to black patients.
In March 2003, the FDA approved the same indication for Merck’s antihypertensive drug Cozaar (losartan potassium tablets). Hyzaar (losartan potassium-hydrochlorothiazide tablets) and Cozaar are the only angiotensin II receptor blockers (ARBs) to be indicated to reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy (LVH).
In addition to the new indication for Hyzaar to reduce the risk of stroke in patients with hypertension and LVH, Hyzaar is also the only combination antihypertensive product that is indicated for initial use in appropriate patients with severe hypertension