Cipla Cancer drug Lenalidomide bags USFDA okay

Published On 2022-09-07 10:52 GMT | Update On 2022-09-07 10:52 GMT

Mumbai: Drugmaker, Cipla Limited, today announced that the company has received final approval for its Abbreviated New Drug Application (ANDA) for Lenalidomide Capsule 5 mg, 10 mg, 15 mg and 25 mg from the United States Food and Drug Administration (USFDA).Cipla's Lenalidomide Capsules are the AB-rated therapeutic equivalent generic version of Bristol Myers Squibb's (Celgene)...

Mumbai: Drugmaker, Cipla Limited, today announced that the company has received final approval for its Abbreviated New Drug Application (ANDA) for Lenalidomide Capsule 5 mg, 10 mg, 15 mg and 25 mg from the United States Food and Drug Administration (USFDA).

Cipla's Lenalidomide Capsules are the AB-rated therapeutic equivalent generic version of Bristol Myers Squibb's (Celgene) Revlimid (Lenalidomide) Capsules.

Lenalidomide is an immunomodulatory prescription drug that 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 $ 2.58 billion for the 12-month period ending June 2022.

"The product will be available for shipping soon," the company stated.

Cipla Limited is an Indian multinational pharmaceutical and biotechnology company, headquartered in Mumbai, India. The Company was founded by Khwaja Abdul Hamied in 1935 in Mumbai. Cipla primarily develops medicines to treat respiratory, cardiovascular disease, arthritis, diabetes, weight control, depression, and other medical conditions. It has 34 manufacturing units in 8 locations across India and a presence in over 80 countries.

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Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Desk Editor for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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Cipla Cancer drug Lenalidomide bags USFDA okay

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