Lupin receives US FDA approval for Lenalidomide capsules
The product will be manufactured at Lupin’s Pithampur facility in India.
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).