Zydus Lifesciences gets FDA final approval for BP drug generic version

Zydus Lifesciences (previously Cadila Healthcare) has secured final approval for Bisoprolol Fumarate and Hydrochlorothiazide tablets USP, 2.5 mg/6.25 mg, 5 mg/6.25 mg, 10 mg/6.25 mg from the US Food and Drug Administration (FDA).

Bisoprolol Fumarate and Hydrochlorothiazide tablets is a generic version of Ziac tablets.

The combination of Bisoprolol Fumarate and hydrochlorothiazide has approval for the treatment of high blood pressure (hypertension).

Zydus Lifesciences gets FDA final approval for Bisoprolol Fumarate and Hydrochlorothiazide tablets. Photo courtesy of Zydus Cadila.

Zydus Lifesciences will manufacture the drug at its formulation manufacturing plant at Ahmedabad SEZ.

According to IQVIA MAT Sep 2022, Bisoprolol Fumarate and Hydrochlorothiazide tablets had sales of $27.1 million per year in the US.

Zydus Lifesciences has taken its approvals to 331 and to date has filed more than 428 abbreviated new drug applications (ANDAs) since the start of the filing process in FY 2003-04.