NATCO receives Tentative Approval for Erdafitinib Tablets from USFDA

NATCO Pharma Limited (BSE: 524816 and NSE: NATCOPHARM) ("NATCO") today received tentative approval from the U.S. FDA for Erdafitinib, 3 mg, 4mg, and 5 mg, a generic version of Balversa® by Janssen Biotech Inc.

NATCO's Erdafitinib is indicated for the treatment of adult patients with locally advanced unresectable or metastatic urothelial carcinoma harbouring susceptible FGFR3 genetic alterations who have disease progression during at least 1 line of prior therapy.

Erdafitinib tablets had estimated sales of approximately USD 60 million in the U.S. for 12 months ending Sep'25 as per industry sales data.

Shares of Natco Pharma Limited was last trading in BSE at Rs. 853.40 as compared to the previous close of Rs. 823.50. The total number of shares traded during the day was 36202 in over 1967 trades.

The stock hit an intraday high of Rs. 880.05 and intraday low of 845.50. The net turnover during the day was Rs. 30910761.00.

Source : Equity Bulls

Keywords

NatcoPharma INE987B01026 Pharmaceuticals TentativeApproval Erdafitinib Tablets USFDA