Zydus Lifesciences gets USFDA approval for Metoprolol Tartrate Tablets

Zydus Lifesciences Limited regulatory filing on Thursday that it 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).

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

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.

Further, Metoprolol belongs to a class of drugs known as beta blockers. It works by blocking the action of certain natural chemicals in the body, such as epinephrine, on the heart and blood vessels. This effect lowers the heart rate, blood pressure, and strain on the heart. 

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). 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.