Zydus Lifesciences gets final nod to market Bisoprolol Fumarate and Hydrochlorothiazide tablets

08 Nov 2022 Evaluate

Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) to market Bisoprolol Fumarate and Hydrochlorothiazide tablets USP, 2.5 mg/6.25 mg, 5 mg/6.25 mg, 10 mg/6.25 mg (USRLD: Ziac tablets).

Bisoprolol Fumarate and hydrochlorothiazide combination is indicated to treat high blood pressure (hypertension). The drug will be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ, India. Bisoprolol Fumarate and Hydrochlorothiazide tablets had annual sales of $27.1 mn in the United States according to IQVIA data (IQVIA MAT Sep 2022). The group now has 331 approvals and has so far filed over 428 ANDAs since the commencement of the filing process in FY 2003-04.

Zydus Lifesciences (formerly known as Cadila Healthcare) is an India-based pharmaceutical company.

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