NATCO announces tentative approval to its ANDA for Trabectedin

NATCO announces tentative approval to its ANDA for Trabectedin

By: IPP Bureau

Last updated : August 18, 2022 11:06 am



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


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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NATCO USFDA

First Published : August 18, 2022 12:00 am