Natco Pharma shares jump 5% as company files for generic cancer drug approval with USFDA
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Shares of Natco Pharma jumped nearly 5% to Rs 1,569 in Friday's intraday trade on BSE after the firm submitted a product application with the US health regulator for a generic product indicated for the treatment of metastatic non-small cell lung cancer. The company has submitted an abbreviated new drug application (ANDA) containing a paragraph IV certification with the US Food and Drug Administration (FDA) for the generic version of Novartis' Tabrecta (Capmatinib hydrochloride), it said in a regulatory filing. The drug firm believes it is the first company to have filed a substantially complete ANDA containing a Paragraph IV Certification for this product and expects to be eligible for 180 days of sole marketing exclusivity at the time of the potential launch of the product under certain circumstances, it added. Industry estimates show that Tabrecta recorded sales of USD 126 million in the US market for 2023, translating to Rs 1,0...