Dr. Reddy’s Laboratories announced that it has received final approval from the Food and Drug Administration (FDA) for its Abbreviated New Drug Application for Lenalidomide Capsules, a therapeutic generic equivalent of Revlimid, for the 2.5mg and 20mg dosage strengths. The Company also received tentative approval for the 5mg, 10mg, 15mg, and 25mg strengths.
Lenalidomide, a thalidomide analogue, is indicated for the treatment of adult patients with:
- Multiple myeloma in combination with dexamethasone;
- Multiple myeloma, as maintenance following autologous hematopoietic stem cell transplantation;
- Transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities.
Dr. Reddy’s generic product is supplied as 2.5mg capsules in 28- and 100-count bottles and 20mg capsules in 21- and 100-count bottles. In a press release, the Company stated that it would be able to sell volume-limited amounts of product after March 2022.
“We are pleased with the Agency’s approval of Lenalidomide Capsules, 2.5mg and 20mg and being eligible for 180-day market exclusivity,” says Marc Kikuchi, CEO, North America Generics, Dr. Reddy’s Laboratories. “We look forward to bringing a more affordable generic version of this drug to market for the benefit of patients.”
- Dr. Reddy’s Laboratories announces approval for lenalidomide capsules from the US Food and Drug Administration (USFDA). News release. Dr. Reddy’s Laboratories. Accessed October 19, 2021. https://www.businesswire.com/news/home/20211018006074/en/Dr.-Reddys-Laboratories-Announces-Approval-for-Lenalidomide-Capsules-from-the-U.S.-Food-and-Drug-Administration-USFDA.
- Lenalidomide Capsules. Package insert. Dr. Reddy’s Laboratories Inc.; 2021. Accessed October 19, 2021. https://www.drreddys.com/pi/final-25mg-20mg.pdf.