NATCO Pharma Ltd.’s shares rose by 2 per cent after the company announced the submission of an abbreviated new drug application (ANDA) to the US Food and Drug Administration (FDA) for the generic version of Erdafitinib tablets in 3 mg, 4 mg, and 5 mg strengths.
Erdafitinib is used to treat adult patients with locally advanced or metastatic urothelial carcinoma. The filing may grant NATCO 180 days of marketing exclusivity upon launch, as it could be the first to file. Balversa®, the branded version of Erdafitinib, recorded sales of $36.5 million in the US market in 2022.
NATCO Pharma’s shares surged by 2 per cent to ₹790 at 02:12 p.m. on BSE.