Zydus Lifesciences gets USFDA nod for generic drug to prevent chest pain in heart patients

New Delhi: Zydus Lifesciences Ltd on Friday said it has received final approval from the US health regulator to manufacture and market its generic Isosorbide Mononitrate extended-release tablets used to prevent chest pain in patients with a certain heart condition.

The approval by the US Food and Drug Administration (USFDA) is to manufacture and market Isosorbide Mononitrate Extended-Release, of strengths 30 mg, 60 mg, and 120 mg, Zydus Lifesciences said in a regulatory filing.

Isosorbide mononitrate is used to prevent chest pain (angina) in patients with a certain heart condition, or coronary artery disease, it added.

The product will be manufactured at the group's formulation manufacturing facility at Ahmedabad SEZ, the company said.

Isosorbide Mononitrate extended-release tablets 30 mg, 60 mg, and 120 mg had annual sales of USD 47 million in the US, Zydus said citing IQVIA December 2023 data.