[ad_1]
Natco Pharma has submitted an abbreviated new drug application to the US Food and Drug Administration for a generic version of Novartis’ cancer drug Tebrecta (capmatinib hydrochloride).
The Hyderabad-based generic drug maker on Thursday said it believes it is the first company to file a substantially complete ANDA, including Paragraph IV certification, and expects to be eligible for 180 days of sole marketing exclusivity for the product at the time of potential launch under certain circumstances.
Tabrecta, indicated for the treatment of adult patients with metastatic non-small cell lung cancer with a specific type of mutation, has projected US market sales of $126 million for 2023. Natco is seeking approval for the generic version of Tabrecta Eq 150 mg base and Eq 200 mg base tablets. Shares of the company closed 2.66% lower at ₹ 1,499.55.
[ad_2]
Source link