Zydus receives Final Approval from the USFDA for Isosorbide Mononitrate Extended-Release, Tablets USP, 30 mg, 60 mg, and 120 mg

Zydus receives Final Approval from the USFDA for Isosorbide Mononitrate Extended-Release, Tablets USP, 30 mg, 60 mg, and 120 mg Ahmedabad, India, February 16, 2024 Zydus Lifesciences Limited (including its subsidiaries/affiliates, hereafter referred to as “Zydus”) 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). The group now has 38 8 approvals and has so far filed over 460* ANDAs since the commencement of the filing process in FY 2003-04. (*as of 31st December 2023) ###

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