Prexxartan Oral Solution Gets Tentative FDA Approval

Prexxartan is an oral solution formulation of valsartan
Prexxartan is an oral solution formulation of valsartan

The Food and Drug Administration (FDA) has tentatively approved Prexxartan (valsartan; Medicure) Oral Solution. 

Prexxartan is indicated for:

  • the treatment of hypertension in adults and children 6 years and older, to lower blood pressure
  • the treatment of heart failure (NYHA class II-IV) to reduce the risk of hospitalization for heart failure in patients who are unable to swallow valsartan tablets; and
  • to reduce the risk of cardiovascular death in clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction who are unable to swallow valsartan tablets

The FDA's final approval is pending the period of patent and/or exclusivity protection, and may not be made effective until the period has expired. 

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Prexxartan, an angiotensin II receptor blocker (ARB), blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II in many tissues, such as vascular smooth muscle and the adrenal gland. 

Prexxartan will be available as a 4mg/mL strength solution. It is anticipated to launch before the end of the first quarter of 2018.

For more information call (888) 435-2220 or visit Medicure.com.