Cipla receives US FDA approval for Revlimid (Lenalidomide) capsules
Drug Approval

Cipla receives US FDA approval for Revlimid (Lenalidomide) capsules

Depending on the type of cancer, it can be used as monotherapy or combination as a part of first line regimen, maintenance regimen or relapsed settings

  • By IPP Bureau | September 08, 2022

Cipla Limited has received final approval for its Abbreviated New Drug Application (ANDA) for Revlimid (Lenalidomide) capsulec 5 mg, 10 mg, 15 mg and 25 mg from the United States Food and Drug Administration (US FDA).

Cipla’s Lenalidomide capsules are AB-rated therapeutic equivalent generic versions of Bristol Myers Squibb’s (Celgene) Revlimid (Lenalidomide) Capsules.

Lenalidomide is an immunomodulatory prescription drug which is indicated for several hematological malignancies in adults such as Multiple Myeloma, Myelodysplastic syndromes, Mantle cell lymphoma, Follicular lymphoma, and Marginal Zone lymphoma.

Depending on the type of cancer, it can be used as monotherapy or combination as a part of first line regimen, maintenance regimen or relapsed settings.

Lenalidomide capsules are not to be used in pregnant women. It is not known if lenalidomide is safe and effective in children. Lenalidomide Capsules should not be used to treat people with chronic lymphocytic leukemia (CLL) outside of a controlled clinical trial.

According to IQVIA (IMS Health), Revlimid (Lenalidomide) capsules had US sales of approximately US $2.58 billion for the 12-month period ending June 2022. The product will be available for shipping soon.

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