Natco Pharma Seeks USFDA Approval For New Generic Metastatic Cancer Drug
Natco Pharma files ANDA for Tabrecta generic, seeking first-to-file exclusivity for lung cancer drug.
Natco Pharma Ltd. revealed on Thursday that it has filed a
product application with the US Food and Drug Administration (FDA) for a
generic version of a drug used to treat metastatic non-small cell lung cancer.
The company submitted an abbreviated new drug application (ANDA) with a
Paragraph IV certification for its generic of Novartis' Tabrecta (Capmatinib
hydrochloride), as detailed in a regulatory report.
Natco Pharma believes it is the first to submit a complete
ANDA with this certification for the product and anticipates securing 180 days
of exclusive marketing rights upon a potential product launch, contingent on
certain conditions. Industry data shows that Tabrecta generated $126 million in
sales in the US in 2023. The drug is prescribed for adult patients with a
specific mutation of metastatic non-small cell lung cancer. Following the
announcement, Natco Pharma’s shares fell by 2.66% to Rs 1,499.55, contrasting
with a 0.43% increase in the BSE Sensex.
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