FDA Approves Valsartan the First Oral Liquid 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 final approved oral liquid dosage form of the angiotensin II receptor blocker valsartan in the United States.

Previously, on October 31, 2017, Medicure declared that, through its subsidiary, Medicure International, Inc., it had gained a permit 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 utilizing its current commercial sales force and framework with an objective 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 old and more to reduce blood pressure to decrease the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.

From a wide variety of pharmacologic classes including the class to which valsartan mainly belongs, in controlled trials of antihypertensive medications these advantages have been seen. There are no controlled trials in hypertensive patients showing risk reduction with valsartan.

It is also indicated for the treatment of heart failure patients (New York Heart Association class II-IV) to significantly decrease hospitalization in the individuals who can’t 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 the individuals who can’t swallow valsartan tablets.

The valsartan oral solution prescribing data contains a boxed cautioning for fetal toxicity. Some antihypertensive medications have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive medications have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease).

These considerations may manage the selection of treatment. PREXXARTAN might be utilized alone or in combination with other antihypertensive agents.


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