Natco Pharma submits abbreviated new drug application with USFDA for generic cancer drug
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 potential launch of the product under certain circumstances.
Natco Pharma on Thursday said it has 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 potential launch of the product under certain circumstances, it added.
As per industry estimates, Tabrecta recorded sales of USD 126 million in the US market for the year 2023.
Capmatinib hydrochloride is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a specific type of mutation.
Shares of Natco Pharma on Thursday ended 2.66 per cent down at Rs 1,499.55 apiece on the BSE.
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