Nilceya (nilotinib) / Cipla - LARVOL DELTA

A US-based subsidiary of drugmaker Cipla is recalling over 400 cartons of generic anti-cancer medication due to a manufacturing issue, according to the US Food and Drug Administration. (The Economic Times) - "Cipla USA is recalling Nilotinib Capsules in two strengths (150 mg and 200 mg), the US health regulator said."

Commercial • Chronic Myeloid Leukemia

Cipla receives US FDA approval for Nilotinib Capsules to treat Chronic Myeloid Leukemia (CNBC-TV18) - "Cipla has received final approval from the US Food and Drug Administration (FDA) for its New Drug Application (NDA) for Nilotinib Capsules in 50 mg, 150 mg, and 200 mg dosages. Nilotinib is indicated for the treatment of Philadelphia Chromosome Positive Chronic Myeloid Leukemia (CML), a cancer that affects the bone marrow and blood....The company plans to launch Nilotinib in the United States during the financial year 2025-26, providing an important new treatment option for CML patients in the US market....Sales from Cipla's largest market, the US, declined by 2% year-on-year to $226 million, though this was still better than the anticipated $218 million."

ANDA • Generic launch • Sales • Chronic Myeloid Leukemia