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A generic version of lenalidomide capsules has been approved by the FDA for MDS and MM

Oct 22, 2021

On October 19, 2021, the U.S. Food and Drug Administration (FDA) approved an abbreviated new drug application for a generic version of lenalidomide capsules, a thalidomide analogue, for oral use in patients with multiple myeloma (MM) and myelodysplastic syndromes (MDS).1 The approval includes 2.5 mg and 20 mg strengths, and a tentative approval for 5 mg, 10 mg, 15 mg, and 25 mg strengths.

Lenalidomide capsules are used for the treatment of adult patients with:

  • MM, in combination with multiple regimens for the treatment of newly diagnosed and relapsed/refractory patients.
  • MM, as maintenance therapy following autologous hematopoietic stem cell transplantation. Read the National Institute for Health and Care Excellence (NICE) recommendation here.
  • Transfusion-dependent anemia due to low- or intermediate-1-risk MDS associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities. Find out more about this on the MDS Hub.
  • Chronic lymphocytic leukemia, only for use as part of controlled clinical trials.

You can find the full prescribing, safety information and black box warning here.

  1. Dr. Reddy's. Dr. Reddy's Laboratories announces approval for lenalidomide capsules from the U.S. Food and Drug Administration (USFDA). Published Oct 19, 2021. Accessed Oct 20, 2021.