Zydus Lifesciences bags FDA final approval for Apixaban Tablets

Zydus Lifesciences has bagged final approval from the US Food and Drug Administration (FDA) for Apixaban Tablets, 2.5mg and 5mg, a generic version of Eliquis Tablets.

Apixaban inhibits the activity of certain clotting compounds in the blood. It reduces the chance of suffering from stroke or blood clots in patients with a heart rhythm disorder called atrial fibrillation.

Besides, Apixaban is used for lowering the chances of developing blood clots in the lungs and legs of those who just underwent knee or hip replacement surgery. It is also used in treating blood clots within the veins in the legs or the lungs, as well as to reduce the possibility of them happening over and over.

Zydus Lifesciences bags FDA final approval for Apixaban Tablets. Photo courtesy of Zydus Cadila.

This drug will be produced at Zydus Lifesciences’ manufacturing facility for formulations in Moraiya, Ahmedabad, India.

Apixaban Tablets 2.5mg, and 5mg, had annual sales of $18,876 million across the US, according to IQVIA MAT December 2022.

Zydus Lifesciences currently has 347 approvals, and has already filed more than 440 abbreviated new drug applications (ANDAs) since the beginning of the process to file in the fiscal year 2003-04.