Unichem Laboratories gets USFDA nod for generic Nebivolol tablets

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.

Unichem Labs | The company has received ANDA approval for its Guanfacine tablets, USP 1 mg and 2 mg, from the United States Food and Drug Administration (USFDA) to market a generic version of TENEX (Guanfacine) tablets 1 mg and 2 mg of Promius Pharma LLC. Guanfacine tablets are indicated in the management of hypertension. The product will be commercialized from Unichem’s Ghaziabad plant.

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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.