Zydus Lifesciences gets USFDA approval to market generic high blood pressure drug

Zydus Lifesciences on Tuesday said it has received final approval from the US health regulator to market its generic version of bisoprolol fumarate tablets used to treat high blood pressure. The approval granted by the US Food and Drug Administration (USFDA) is for bisoprolol fumarate tablets of strengths 5 mg and 10 mg, Zydus Lifesciences Ltd said in a regulatory filing. The drug will be manufactured at the group's formulation manufacturing facility at, SEZ, Ahmedabad, and will be distributed by Viona Pharmaceuticals Inc, it added.

Bisoprolol Fumarate Tablets are used to treat high blood pressure either alone or in combination with other high blood pressure medications. As per IQVIA May 2022 data, the company said bisoprolol fumarate tablets had annual sales of USD 30 million in the US.