FDA Approves the First Oral Liquid for Valsartan in the U.S.

Valsartan was first FDA-approved in 2001 as Diovan tablets

The FDA has approved valsartan oral solution (Prexxartan, Medicure), the first and only approved oral liquid dosage form of the angiotensin II receptor blocker valsartan in the United States.

Previously, on October 31, 2017, Medicure announced that, through its subsidiary, Medicure International, Inc., it had acquired a license to sell and market valsartan oral solution in the United States and its territories for a seven-year term, with potential extensions to the term available. The company intends to launch the product using its existing commercial sales force and infrastructure with a target commercial launch date during the first half of 2018.

Valsartan oral solution is indicated for the treatment of hypertension in adults and children 6 years of age and older to lower blood pressure to reduce the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. It is also indicated for the treatment of heart failure patients (New York Heart Association class II–IV) to significantly reduce hospitalization in those who are unable to swallow valsartan tablets; and for the treatment of patients with stable left ventricular failure or left ventricular dysfunction following myocardial infarction to reduce cardiovascular mortality in those who are unable to swallow valsartan tablets. The valsartan oral solution prescribing information contains a boxed warning for fetal toxicity.

Sources: Medicure and FDA; December 19, 2017.