Cipla Limited has announced that it has received final approval from the United States Food and Drug Administration (USFDA) for its New Drug Application (NDA) for Nilotinib Capsules 50, 150, and 200 mg. This approval, granted on 19th February 2025, marks a major milestone in the treatment of Philadelphia chromosome-positive chronic myeloid leukemia (CML), a type of blood cancer.
In the exchange filing, the company stated that Nilotinib is an oncology product in capsule form, designed for oral consumption. It is specifically used for the treatment of chronic myeloid leukemia (CML), particularly in patients who are Philadelphia chromosome-positive.
Cipla plans to launch Nilotinib Capsules in the United States of America during the financial year 2025-26.
In the meantime, on February 8, the company announced that its Virgonagar manufacturing facility in Bengaluru has received a “Voluntary Action Indicated” (VAI) classification from the United States Food and Drug Administration (USFDA). This follows a routine cGMP inspection conducted from November 7-13, 2024. The official communication was received on February 7, 2025. This reaffirms Cipla’s commitment to maintaining high-quality manufacturing practices.
