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Lupin today announced that it has received approval from the United States Food and Drug Administration (U.S. 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 U.S. (IQVIA MAT July 2025).
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