NATCO Pharma Limited announced that the U.S. Food and Drug Administration has granted tentative approval to its Abbreviated New Drug Application (ANDA) for Trabectedin for Injection (generic for Yondelis® ) for the 1mg/vial presentation.

According to industry sales data, Yondelis generated annual sales of $49.7 million for the twelve months ending June 2022 in the US market.

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