Scienture (SCNX) said Tuesday the US Food and Drug Administration approved its new drug application for Arbli, an oral suspension formulation of hypertension drug losartan potassium.
The company said Arbli is indicated for hypertension in patients older than 6 years old, stroke risk reduction in patients with hypertension and left ventricular hypertrophy, and diabetic nephropathy in certain patients with type 2 diabetes.
The company also said the product has two patents and is expected to be listed in the FDA's Orange Book.
Scienture said it plans to launch Arbli in the US in Q3.
Shares of the company were up more than 24% in recent Tuesday premarket activity.
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