Unichem Laboratories on Wednesday said it has received approval from the US health regulator to market its generic version of Nebivolol tablets indicated for the treatment of hypertension.
The approval by the US Food and Drug Administration (USFDA) for the abbreviated new drug application (ANDA) of Nebivolol tablets is for strengths of 2.5 mg, 5 mg, 10 mg, and 20 mg, the company said in a regulatory filing.
The product is a generic version of Bystolic of Allergan Sales, LLC, and will be commercialized from Unichem's Ghaziabad plant, it added.
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