Natco Pharma Receives US Approval for Generic Cancer Drug

Natco Pharma gains US regulatory approval for a generic version of Janssen's Balversa, used to treat advanced urothelial carcinoma. The newly approved medication is expected to enter a market valued at $60 million in annual sales. Natco Pharma shares rose 3.39% following the announcement.

Natco Pharma, a pharmaceutical company, announced on Tuesday that it has secured approval from the US health regulator for its generic cancer medication.

The company received tentative approval for the drug Erdafitinib, equivalent to Janssen Biotech Inc's Balversa, in tablets of 3 mg, 4 mg, and 5 mg. Erdafitinib is designated for use in treating adult patients with specific genetic alterations related to urothelial carcinoma.

According to industry data, sales of Erdafitinib tablets in the US for the 12 months leading up to September 2025 are projected to be around USD 60 million. In response, Natco Pharma shares rose by 3.39% to Rs 851.45 on the BSE.

(With inputs from agencies.)