Cipla Gets the Final Approval for Generic Version of Revlimid by US FDA

On September 7’th, 2022, Cipla Ltd announced that it has received final approval for its generic version (ANDA) of Lenalidomide Capsule 5 mg, 10 mg, 15 mg and 25 mg from the US FDA.

As per company’s press statement, Cipla’s Lenalidomide Capsules are the AB-rated therapeutic identical generic version of Bristol Myers Squibb’s (Celgene) Revlimid® (Lenalidomide) Capsules.

What is Lenalidomide: Lenalidomide is a pharmaceutical medicinal product that is identical to thalidomide and is used alone or along with other medicines to treat adults with several hematological malignancies such as follicular lymphoma, mantle cell lymphoma (MCL), marginal zone lymphoma, multiple myeloma (MM), or anemia caused by certain sorts of myelodysplastic syndromes (MDS). This pharmaceutical medicine is also being studied in the treatment of certain other conditions and types of cancer. 

Lenalidomide treatment is believed to help the immune system destroy the abnormal blood cells or cancerous cells. It is also known for preventing the progression of new blood vessels that the tumors need to replicate.

Lenalidomide is designated as an antiangiogenesis agent and a kind of immunomodulating agent. It is also called CC-5013 and typically supplied under the brand name Revlimid. 

As per the nature/type of cancer, this medicinal product can be used as monotherapy or together as a part of first line regimen, maintenance regimen or relapsed settings.

The capsules of Lenalidomide are not for those who are pregnant. It is not specified if this medication is safe and useful in children.

The medicinal product will be available for shipping soon in the pharmaceutical market.

Source:

https://www.cipla.com/press-releases-statements/cipla-receives-usfda-approval-generic-version-revlimid-lenalidomide-capsule