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Natco Pharma’s cancer drug copy gets U.S. FDA’s tentative nod

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Natco Pharma has received the U.S. Food and Drug Administration’s (FDA) tentative approval for Trabectedin for Injection, the company’s generic version of cancer medicine Yondelis.

Its abbreviated new drug application (ANDA) for the 1mg/vial presentation of Trabectedin for Injection has got the tentative approval. Yondelis generated $ 49.7 million annual sales for the 12 months ended June 2022 in the U.S. market, the Hyderabad-based drugmaker said, citing industry sales data.

According to U.S. FDA, Yondelis (trabectedin) is indicated for treatment of patients with unresectable or metastatic liposarcoma or leiomyosarcoma, who received a prior anthracycline-containing regimen.

On Wednesday, Natco Pharma shares declined 1% to close at ₹651.30 on the BSE.



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