Lupin announced that it has received approval from the United States Food and Drug Administration (US FDA) for its Abbreviated New Drug Application for Lenalidomide Capsules, 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg and 25 mg.
Lenalidomide capsules are bioequivalent to Revlimid capsules, 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg, of Bristol-Myers Squibb Company. This product will be manufactured at Lupin’s Pithampur
facility in India.
Lenalidomide Capsules are indicated for the treatment of adult patients with:
Multiple myeloma (MM), in combination with dexamethasone
MM, as maintenance following autologous hematopoietic stem cell transplantation (auto-HSCT)
Transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes
(MDS) associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities.
Lenalidomide Capsules, 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg and 25 mg (RLD Revlimid) had estimated annual sales of USD 7,511 million in the US (IQVIA MAT July 2025).