Cipla Obtained USFDA Approval for Nilotinib Capsules to Treat CML

Pharmaceutical industry Cipla has obtained final approval from the United States Food and Drug Administration (USFDA) for the New Drug Application (‘NDA’) it submitted for ‘Nilotinib Capsules 50, 150, and 200 mg’.

Nilotinib is an oncology product available in capsule form for oral use and is prescribed for the treatment of chronic myeloid leukemia (CML) positive for the Philadelphia chromosome. Chronic myeloid leukemia positive for the Philadelphia chromosome is a type of bone marrow cancer resulting from a genetic accident.

The product is anticipated to be introduced in fiscal year 2025-26 in the United States of America.

The Medical Dialogues team previously reported that Cipla had finalized an investment of around. ZAR 900 million invested in Cipla Medpro South Africa Proprietary Limited, a fully owned subsidiary situated in South Africa, in exchange for 40,742,417 shares. CMSA is a fully owned subsidiary of Cipla Limited and serves as the holding company for the group's operations in South Africa. The group engages in the manufacturing, marketing, and distribution of pharmaceutical products. The invesments will be used to lower inter-group debt and enhance the capital structure of CMSA and its subsidiaries, the Company announced.

Cipla is an international pharmaceutical firm dedicated to agile and sustainable expansion, complex generics, and enhancing its portfolio in its core markets of India, South Africa, North America, and important regulated and emerging markets. It possesses advantages in the respiratory, anti-viral, urology, cardiology, anti-infective, and CNS fields.