USFDA gives approval for this cancer drug

Cipla's Lenalidomide capsules are therapeutic equivalent generic version of Bristol Myers Squibb's Revlimid (Lenalidomide) capsules.

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USFDA Drug product Approval
USFDA Approval

New Delhi: Drug firm Cipla said it has received approval from the US health regulator for Lenalidomide capsule, a drug used to treat various types of cancer.

The company has received the final approval from the US Food and Drug Administration (USFDA) for the product in strengths of 5 mg, 10 mg, 15 mg, and 25 mg, Cipla said in a regulatory filing.

Cipla’s Lenalidomide capsules are therapeutic equivalent generic versions of Bristol Myers Squibb’s Revlimid (Lenalidomide) capsules.

Lenalidomide is an immunomodulatory prescription drug 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 in combination as a part of the first-line regimen, maintenance regimen, or relapsed setting.

According to IQVIA (IMS Health), Revlimid capsules had sales of around USD 2.58 billion in the US for the 12-month period ending June 2022.

The product will be available for shipping soon, Cipla noted.

Shares of the company were trading 1.95 percent up at Rs 1,061 apiece on the BSE.

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