Natco Pharma Gets USFDA Nod for Cancer Drug
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Natco Pharma receives USFDA approval for generic Erdafitinib, a cancer drug. Expected US sales of Balversa generic are around USD 60 million.
New Delhi, Feb 3 (PTI) 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 USD 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. PTI MSS MSS DR
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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 USD 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. PTI MSS MSS DR
DR
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