New Delhi: On Thursday, Natco Pharma announced that it has filed a product application with the U.S. Food and Drug Administration (FDA) for a generic version of a drug used to treat metastatic non-small cell lung cancer (NSCLC). The company’s application is an abbreviated new drug application (ANDA) that includes a paragraph IV certification, aimed at producing a generic version of Novartis' Tabrecta (Capmatinib hydrochloride), as per the company's regulatory filing.
Natco Pharma believes it is the first to submit a substantially complete ANDA with a Paragraph IV Certification for this particular product, potentially qualifying it for 180 days of exclusive marketing rights upon the product's launch, subject to certain conditions.
Industry reports indicate that Tabrecta generated $126 million in sales in the U.S. market in 2023. Capmatinib hydrochloride is prescribed for the treatment of adult patients with NSCLC who have a specific type of mutation.
On Thursday, Natco Pharma's shares closed 2.66% lower at Rs 1,499.55 on the BSE.
(Input from various sources)
(Rehash/Ankur Deka/MSM)