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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Net profit of Natco Pharma declined 26.67% to Rs 159.50 crore in the quarter ended December 2018 as against Rs 217.50 crore during the previous quarter ended December 2017. Sales declined 0.98% to Rs 556.70 crore in the quarter ended December 2018 as against Rs 562.20 crore during the previous quarter ended December 2017.

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Natco Pharma announced that the Board of Directors of the Company at its meeting held on 12 February 2019, has recommended a Second Interim dividend of Rs.3.5 per share(i.e.175%), subject to the approval of the shareholders.

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Natco Pharma will hold a meeting of the Board of Directors of the Company on 12 February 2019.

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