Zydus receives USFDA approval for Lenalidomide capsules

Ahmedabad: Zydus Lifesciences has received approval from the United States Food and Drug Administration (USFDA) to market Lenalidomide Capsules, USP 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg. The company has received final approvals for 5 mg, 10 mg, 15 mg and 25 mg strengths and tentative approvals for 2.5 mg and 20 mg strength.

Lenalidomide is used to treat various types of cancers by slowing or stopping the growth of cancer cells. It is also used to treat anaemia in patients with certain blood/bone marrow disorders. The drug will be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ, India.

Lenalidomide had annual sales of USD 2.86 bn in the United States, according to IQVIA MAT July 2022. The product would soon be launched in the US market.