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Natco Pharma Ltd announced the final approval of Abbreviated New Drug Application (ANDA) for Imatinib Mesylate tablets from the US Food and Drug Administration (USFDA).
The tablets will be marketed in the US market by the Hyderabad-based Natco’s marketing partner Lupin as generic version of Novartis Pharmaceuticals Corporation’s Gleevec tablets. Imatinib Mesylate tablet is indicated primarily for the treatment of patients with specific types Chronic Myeloid Leukemia. They had annual sales of approximately $655 million in the US, according to a release.
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