Cipla bags USFDA nod for chronic myeloid leukemia drug Nilotinib

Written By : Ruchika Sharma |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2025-02-21T11:30:27+05:30 | Updated On 21 Feb 2025 12:09 PM IST

Govt extends deadline for submitting applications under PLI Scheme

Mumbai: Pharma major, Cipla, has received final approval from the United States Food and Drug Administration (USFDA) for the New Drug Application (‘NDA’) submitted for ‘Nilotinib Capsules 50, 150 and 200 mg’.

Nilotinib is an oncology category product in capsule form for oral consumption and is used for treatment of philadelphia chromosome positive chronic myeloid leukemia (CML).

Philadelphia chromosome positive chronic myeloid leukemia is a bone marrow cancer that is caused by a genetic accident.

The product is expected to be launched in FY 2025-26 in the United States of America.

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Medical Dialogues team had earlier reported that Cipla had completed an investment of approx. ZAR 900 million in Cipla Medpro South Africa Proprietary Limited, South Africa, a wholly owned subsidiary in South Africa against allotment of 40,742,417 shares. CMSA, is a wholly owned subsidiary of Cipla Limited, and is the holding company for the group operations in South Africa.The group is involved in the manufacturing, marketing, and supply of pharmaceutical products. The investment will be utilised to reduce inter-group debt and improve the capital structure of CMSA and its subsidiaries, the Company had said.

Read also: Cipla completes investment of ZAR 900 million in South Africa subsidiary

Established in 1935, Cipla is a global pharmaceutical company focused on agile and sustainable growth, complex generics, and deepening portfolio in its home markets of India, South Africa, North America, and key regulated and emerging markets. It has strengths in the respiratory, anti-retroviral, urology, cardiology, anti-infective, and CNS segments. It has 47 manufacturing sites around the world which produces 50+ dosage forms and 1,500+ products using cutting-edge technology platforms to cater to its 80+ markets.

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Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent 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

Dr. Kamal Kant Kohli

Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751