Natco Pharma Seeks USFDA Approval For New Generic Metastatic Cancer Drug

Natco Pharma Ltd. revealed on Thursday that it has filed a product application with the US Food and Drug Administration (FDA) for a generic version of a drug used to treat metastatic non-small cell lung cancer. The company submitted an abbreviated new drug application (ANDA) with a Paragraph IV certification for its generic of Novartis' Tabrecta (Capmatinib hydrochloride), as detailed in a regulatory report.

Natco Pharma believes it is the first to submit a complete ANDA with this certification for the product and anticipates securing 180 days of exclusive marketing rights upon a potential product launch, contingent on certain conditions. Industry data shows that Tabrecta generated $126 million in sales in the US in 2023. The drug is prescribed for adult patients with a specific mutation of metastatic non-small cell lung cancer. Following the announcement, Natco Pharma’s shares fell by 2.66% to Rs 1,499.55, contrasting with a 0.43% increase in the BSE Sensex.