Lupin Ltd Receives U.S. FDA Approval for Lenalidomide Capsules

Lupin Ltd, a global pharmaceutical leader, has announced that it has received approval from the 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. The product will be manufactured at Lupin’s Pithampur facility in India and is bioequivalent to Revlimid® Capsules. Lenalidomide Capsules are indicated for the treatment of multiple myeloma, transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with a deletion 5q abnormality, and as maintenance following autologous hematopoietic stem cell transplantation. The estimated annual sales of the RLD Revlimid® in the U.S. are USD 7,511 million.