Natco Pharma gets USFDA approval for lmatinib Mesylate Tablets

Natco Pharma announced the final approval of Abbreviated New Drug Application (ANDA) from the U.S. Food and Drug Administration (FDA) for lmatinib Mesylate Tablets, 100 mg (base) and 400 mg (base). These Tablets will be marketed in the USA by Natco's marketing partner Lupin, as generic versions of Novartis Pharmaceuticals Corporation's (Novartis) Gleevec Tablets, 100mg and 400mg.

lmatinib Mesylate Tablet is indicated primarily for the treatment of patients with specific types of Chronic Myeloid Leukemia (CML). Imatinib Mesylate Tablets, 100 mg (base) and 400 mg (base) had annual sales of approximately USD 655 million in the US (IQVIA MAT December 2018).

 

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