Industry

USFDA gives nod to Glenmark this for Blood Pressure drug

Bisoprolol fumarate and hydrochlorothiazide tablets to treat high blood pressure.

January 29, 2022

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USFDA Drug product Approval — USFDA Approval

Last Updated on December 31, 2023 by The Health Master

Glenmark Pharmaceuticals Ltd. announced that its U.S. subsidiary received final approval by the country’s regulator (USFDA) for generic Bisoprolol fumarate and hydrochlorothiazide tablets to treat high blood pressure.

According to a statement, Glenmark Pharmaceuticals Inc., U.S.A was granted approval for Bisoprolol Fumarate tablets in strengths of 2.5 mg/6.25mg, 5 mg/6.25mg, and 10 mg/6.25 MG.

Click for more on USFDA

These generic Ziac tablets are 2.5 mg/6.25mg, 5 mg/6.25mg, and 10 mg/6.25mg, respectively, according to Teva Branded Pharmaceutical Products R&D, Inc.

The company cited IQVIATM sales data from the twelve months ending November 2021 and stated that these Ziac tablets generated approximately $30.3 million in annual sales.

Glenmark stated that its current portfolio includes 172 products authorized for distribution in the U.S. market and 46 abbreviated drug applications pending approval by the USFDA.

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