Natco Pharma Submits Product Application With USFDA For Generic Metastatic Cancer Drug
The pharma major expects to be eligible for 180 days of sole marketing exclusivity when it launches the product under certain circumstances.
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Natco Pharma Ltd. announced on Thursday that the company has submitted a product application with the US Food and Drug Administration for a generic product indicated for the treatment of metastatic non-small cell lung cancer.
The company has submitted an abbreviated new drug application containing a paragraph IV certification with the USFDA 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.
According to the industry estimates, Tabrecta recorded sales of $126 million in the US market in the year 2023.
Capmatinib hydrochloride is indicated for the treatment of adult patients with metastatic non-small cell lung cancer with a specific type of mutation.
Shares of Natco Pharma closed 2.66% lower at Rs 1,499.55 per share, as compared to a 0.43% advance in the BSE Sensex.
(With inputs from PTI)
