Hypertension drug: Zydus Lifesciences gets USFDA approval for Metoprolol Tartrate Tablets

Ahmedabad: Zydus Lifesciences Limited today announced that the company has received final approval from the United States Food and Drug Administration (USFDA) to manufacture and market Metoprolol Tartrate Tablets USP, 25 mg, 50 mg, and 100 mg (USRLD: Lopressor 25 mg, 50 mg and 100 mg).

Metoprolol is used with or without other medications to treat high blood pressure (hypertension). Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems.

This medication is also used to treat chest pain (angina) and to improve survival after a heart attack. Metoprolol belongs to a class of drugs known as beta blockers. It works by blocking the action of certain natural chemicals in body, such as epinephrine, on the heart and blood vessels. This effect lowers the heart rate, blood pressure, and strain on the heart.

The drug will be manufactured at the group’s formulation manufacturing facility in Baddi, Himachal Pradesh, (India).

Metoprolol Tartrate Tablets USP, 25 mg, 50 mg, and 100 mg had annual sales of USD 45.2 mn in the United States (IQVIA MAT Feb. 2023). 

Medical Dialogues team had earlier reported the company had received final approval from the United States Food and Drug Administration (USFDA) for Olmesartan Medoxomil and Hydrochlorothiazide Tablets, 20 mg/12.5 mg, 40 mg/12.5 mg, and 40 mg/25 mg (USRLD: Benicar HCT Tablets).

Read also: Zydus Lifesciences Hypertension drug gets USFDA okay

The group now has 364 approvals and has so far filed over 440* ANDAs since the commencement of the filing process in FY 2003-04.

Zydus Lifesciences Limited (Formerly known as Cadila Healthcare Limited), an Indian Pharmaceutical company is a fully integrated, global healthcare provider. The company was founded in the year 1952 by Mr. Ramanbhai B. Patel (late), a first-generation entrepreneur and a doyen in the field of Indian Pharmaceuticals.