FDA Approves Oral Solution Formulation of Valsartan

First approved oral liquid dosage form of the angiotensin II receptor blocker valsartan
First approved oral liquid dosage form of the angiotensin II receptor blocker valsartan

Medicure has received final approval from the Food and Drug Administration (FDA) for Prexxartan, the first oral liquid dosage form of valsartan, an angiotensin II receptor blocker (ARB).

Prexxartan is indicated for:

  • Hypertension in adults and children ≥6 years of age, to lower blood pressure 
  • Heart failure (NYHA Class II–IV); Prexxartan significantly reduces hospitalization for heart failure in patients who are unable to swallow valsartan tablets
  • Stable left ventricular failure or left ventricular dysfunction following myocardial infarction; Prexxartan reduces cardiovascular mortality in patients who are unable to swallow valsartan tablets

Prexxartan is not therapeutically equivalent to the tablet formulation of Diovan; the peak concentration of valsartan with Prexxartan is higher than with Diovan. 

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Prexxartan will be supplied as a 4mg/mL oral solution packaged in 120mL and 473mL bottles. Medicure expects to launch the product during the first half of 2018.

For more information visit Medicure.com.