NATCO Pharma gets US FDA's tentative approval for Erdafitinib tablets
This story was originally published at 15:12 IST on 3 February 2026
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MUMBAI – NATCO Pharma Ltd. has received tentative approval for Erdafitinib tablets, the company said in a press release without mentioning who gave the approval. A company official confirmed that the approval was from the US Food and Drug Administration.
"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," according to the company.
Erdafitinib is a generic version of the Balversa by Janssen Biotech Inc. The tablets had an estimated sales of around $60 million in the US for 12 months ended September, according to the company.
The Hyderabad-headquartered pharmaceutical company had posted consolidated net profit of INR 5.18 billion and revenue of INR 13.63 billion for the September quarter. At 1454 IST, shares of the company traded at INR 852.15, up over 3% on the National Stock Exchange. End
Reported by Nandini Sinha
Edited by Akul Nishant Akhoury
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