US FDA Approves Generic Hypertension Drug of Zydus Lifesciences


The US Food and Drug Administration (FDA) has approved Zydus Lifesciences’ hypertension drugs Bisoprolol Fumrate and Hydrochlorothiazide tablets in the United States. The US FDA has given clearance to Zydus Lifesciences to market generic medicines in the United States in multiple strengths.

With increasing cases of hypertension, the combination of Bisoprolol Fumrate and hydrochlorothiazide is widely used in India to treat high blood pressure, or hypertension. This generic medication will be produced at the company’s manufacturing plant located in Ahmedabad, India.

Bisoprolol Fumrate and Hydrochlorothiazide tablets have recorded an annual sale of 27.1 million dollars in the United States, says IQVUA MAT data. The shares of Zydus Lifesciences were trading 2.47 higher on the BSE stock index. The shares of the company have performed well for the past five days.

Zydus Lifesciences is all set to announce its quarter 2 earnings result on November 11, 2022, and the company has reported a year-on-year drop in its net profit of 12 percent in its previous quarter.

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The US Food and Drug Administration (FDA) has given an establishment inspection report (EIR) to the Moraiya facility of the company in Gujarat, India. The plant was inspected from July 26, 2022 to August 5, 2022, and four observations. Any kind of regulatory action by US FDA would have made it more difficult for the company to establish products in the United States.