USFDA nod for Natco, Lupin alliance’s cancer drug

Natco Pharma on Wednesday announced the receipt of the final ANDA (Abbreviated New Drug Application) approval from the US Food and Drug Administration for lmatinib Mesylate tablets, 100 mg (base) and 400 mg (base). The product, which is used in the treatment of certain types of cancer, would be marketed in the U.S. by Natco’s marketing partner Lupin as a generic version of Novartis’ Gleevec tablets. A statement from the Hyderabad-headquartered drugmaker said lmatinib Mesylate tablet, indicated primarily for the treatment of patients with specific types of Chronic Myeloid Leukemia, had annual sales of about $655 million in the U.S.

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