Natco Pharma has submitted to the U.S. Meals and Drug Administration an abbreviated new drug software for a generic model of Novartis’ most cancers drug Tabrecta (capmatinib hydrochloride).
The corporate believes it’s the first to have filed a substantially-complete ANDA containing a paragraph IV certification and expects to be eligible for 180 days of sole advertising exclusivity on the time of potential launch, of the product below sure circumstances, the Hyderabad-based generic drugmaker mentioned on Thursday.
Tabrecta, indicated for therapy of grownup sufferers with metastatic non-small cell lung most cancers with a particular kind of mutation, had $126 million gross sales within the U.S. marketplace for 2023. Natco is looking for approval for generic model of Tabrecta Eq 150 mg base and Eq 200 mg base tablets. The corporate’s shares declined 2.66% to shut at ₹1,499.55 every on the BSE.
