US FDA approves new generic valsartan for high blood pressure and heart failure
13 March 2019 -

Public health agency the US Food and Drug Administration stated on Tuesday that it has authorised the new generic version of Diovan (valsartan) for the treatment of high blood pressure and heart failure.

This US FDA approval of the new generic of Diovan was awarded to Alkem Laboratories Limited.

In connection with the approval, the US FDA prioritised the review of this drug application to help relieve the recent shortage of this critical medicine as a result of multiple recalls of generic valsartan products from several manufacturers due to the finding that certain lots of valsartan and other ARB medicines contain nitrosamine impurities. Not all ARB medicines have been recalled. Valsartan is an angiotensin II receptor blocker (ARB) that treats high blood pressure and heart failure.

Following the assessment and evaluation of the company's manufacturing processes and appropriate testing methods, the US FDA concluded that the approved valsartan product does not contain NDMA or NDEA and there is no known risk for the formation of other nitrosamine impurities.

According to the National Heart, Lung, and Blood Institute, high blood pressure is a common disease in which blood flows through blood vessels, or arteries, at higher than normal pressures. Heart failure is a condition in which the heart can't pump enough blood to meet the body's needs.