Zydus Lifesciences Ltd on Thursday said it has received final approval from the US health regulator to manufacture and market its generic version of metoprolol tartrate tablets used to treat high blood pressure.
The approval granted by the United States Food and Drug Administration (USFDA) is for metoprolol tartrate tablets of strengths 25 mg, 50 mg, and 100 mg, Zydus Lifesciences said in a regulatory filing.
The drug will be manufactured at the group's formulation manufacturing facility at Baddi in Himachal Pradesh, it added.
Metoprolol is used with or without other medications to treat high blood pressure (hypertension), the company said, adding the medication is also used to treat chest pain (angina) and to improve survival after a heart attack.
Metoprolol tartrate tablets 25 mg, 50 mg, and 100 mg had annual sales of USD 45.2 million in the US, the company said citing IQVIA MAT February 2023 data.
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