Zydus Lifesciences Gets U.S. FDA Nod To Market Generic Drug
The company has received approval from the U.S. FDA to market Apixaban tablets in strengths of 2.5 and 5 mg.
Zydus Lifesciences on Tuesday said it has received approval from the U.S. health regulator to market a generic medication to prevent and treat blood clots.
The company has received approval from the U.S. Food and Drug Administration 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 Dec. 2022 data, Apixaban tablets had annual sales of $18,876 million in the U.S.
