Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) to manufacture and market Isosorbide Mononitrate Extended-Release, Tablets USP, 30 mg, 60 mg, and 120 mg (USRLD: Imdur Extended-Release Tablets).
Isosorbide mononitrate is used to prevent chest pain (angina) in patients with a certain heart condition (coronary artery disease).
The product will be manufactured at the group's formulation manufacturing facility at Ahmedabad SEZ, India.
Isosorbide Mononitrate Extended-Release, Tablets USP, 30 mg, 60 mg, and 120 mg had annual sales of USD 47 mn in the United States (IQVIA Dec. Nov. 2023).
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