Zydus Lifesciences receives USFDA approval to market generic drug

Zydus Lifesciences on Tuesday said it has received approval from the US health regulator to market a generic medication to prevent and treat blood clots.

The company has received approval from the US Food and Drug Administration (USFDA) to market Apixaban tablets in strengths of 2.5 and 5 mg, according to a regulatory filing.

Apixaban blocks the activity of certain clotting substances in the blood. It is used to lower the risk of stroke or a blood clot in people with a heart rhythm disorder called atrial fibrillation.

It is also used to reduce the risk of forming a blood clot in the legs and lungs of people who have just had hip or knee replacement surgery.

The drug will be manufactured at the Zydus group's formulation manufacturing facility at Moraiya, Ahmedabad.

As per IQVIA MAT December 2022 data, Apixaban tablets had annual sales of USD 18,876 million in the US.