Zydus Lifesciences gets final nod for Isosorbide Mononitrate Extended-Release Tablets

16 Feb 2024 Evaluate

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 $47 million in the United States (IQVIA December. November. 2023). The group now has 388 approvals and has so far filed over 460 ANDAs since the commencement of the filing process in FY 2003-04. 

Zydus Lifesciences (formerly known as Cadila Healthcare) is an India-based pharmaceutical company.

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