Zydus gets US regulator’s nod for Metoprolol Tartrate tablets, used for treating high BP

Zydus Lifesciences on Thursday said it received final approval from the US Food and Drug Administration (FDA) to manufacture and market Metoprolol Tartrate tablets in dosages of 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 improve survival chances after a heart attack. Metoprolol belongs to a class of drugs known as beta-blockers, according to a statement released by Zydus on Thursday. 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, Zydus said.
Metoprolol Tartrate tablets of dosage — 25 mg, 50 mg, and 100 mg — had annual sales of USD 45.2 million in the United States, according to IQVIA MAT of the month, February 2023.

The group now has 364 approvals and has so far filed over 440 abbreviated new drug applications (ANDAs) since the commencement of the filing process in FY2003-04.

Zydus Lifesciences Limited, formerly known as Cadila Healthcare, is an Indian multinational pharmaceutical company headquartered in Ahmedabad, which is primarily engaged in the manufacture of generic drugs. According to Wikipedia, the company ranked 100th in the Fortune India 500 list in 2020.