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Natco Pharma gets US health regulator's nod for generic cancer drug

The company has received tentative approval for Erdafitinib in strengths of 3 mg, 4mg, and 5 mg, the drug firm said in a regulatory filing

Natco Pharma, Natco

Photo: X@pharma_natco

Press Trust of India New Delhi

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Drug firm Natco Pharma on Tuesday said it has received approval from the US health regulator for a generic cancer medication.

The company has received tentative approval for Erdafitinib in strengths of 3 mg, 4mg, and 5 mg, the drug firm said in a regulatory filing.

The company's product is a generic version of Janssen Biotech Inc's Balversa. Natco said Erdafitinib is indicated for the treatment of adult patients with locally advanced unresectable or metastatic urothelial carcinoma harbouring susceptible FGFR3 genetic alterations.

As per the industry sales data, Erdafitinib tablets had estimated sales of around $60 million in the US for 12 months ending September 2025.

 

Shares of Natco Pharma were trading 3.39 per cent up at Rs 851.45 apiece on BSE.

(Only the headline and picture of this report may have been reworked by the Business Standard staff; the rest of the content is auto-generated from a syndicated feed.)

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First Published: Feb 03 2026 | 3:38 PM IST

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