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.


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“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.”

References

  1. 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
  2. Lenalidomide Capsules. Package insert. Dr. Reddy’s Laboratories Inc.; 2021. Accessed October 19, 2021. https://www.drreddys.com/pi/final-25mg-20mg.pdf.



This article originally appeared on MPR