The drug major on Tuesday announced that it has received final approval from the United States Food and Drug Administration (USFDA) for Lenalidomide Capsules, 2.5 mg and 20 mg.
The said drug is equivalent to reference listed drug, Revlimid Capsules.
Lenalidomide capsules are used to treat various types of cancers. It works by slowing or stopping the growth of cancer cells. It is also used to treat anemia in patients with certain blood/bone marrow disorders (myelodysplastic syndromes-MDS). Lenalidomide may lessen the need for blood transfusions.
The pharma company said that the products will be launched in the US market shortly. The drugs will be manufactured at the group's formulation manufacturing facility in SEZ, Ahmedabad (India), it added.
According to IQVIA MAT December 2022 data, Lenalidomide capsules had annual sales of $183 million in the United States.
As of 31 December 2022, the group now has 349 approvals and has so far filed over 440 ANDAs since the commencement of the filing process in FY 2003-04.
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Zydus Lifesciences is a discovery-driven, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies.
The drug maker's consolidated net profit jumped 24.48% to Rs 622.9 crore on a 19.85% increase in total revenue from operations to Rs 4,362.3 crore in Q3 FY23 over Q3 FY22.
Shares of Zydus Lifesciences declined 0.62% to Rs 473.05 on the BSE.
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