Natco Pharma secures USFDA nod for Trabectedin for Injection
Hyderabad: Drugmaker, Natco Pharma Limited has recently announced that the U.S. Food and Drug Administration (USFDA) has granted tentative approval to its Abbreviated New Drug Application (ANDA) for Trabectedin for Injection for the 1mg/vial presentation. The product is the generic version of cancer medicine Yondelis.Yondelis is an alkylating drug indicated for the treatment...
Hyderabad: Drugmaker, Natco Pharma Limited has recently announced that the U.S. Food and Drug Administration (USFDA) has granted tentative approval to its Abbreviated New Drug Application (ANDA) for Trabectedin for Injection for the 1mg/vial presentation. The product is the generic version of cancer medicine Yondelis.
According to industry sales data, Yondelis generated annual sales of $49.7 million for the twelve months ending June 2022 in the US market.
Medical Dialogues team had earlier reported that the U.S. Food and Drug Administration (USFDA) had granted approval to its partner Breckenridge Pharmaceutical Inc's Abbreviated New Drug Application for Cabazitaxel Intravenous Powder (generic for Jevtana Kit) for the 60mg/1.5mL (40mg/mL) strength used for the treatment of prostate cancer.
Read also: Natco partner bags USFDA nod for Cabazitaxel Intravenous Powder
Natco Pharma Limited was incorporated in Hyderabad in the year 1981 with an initial investment of INR 3.3 million.
The company has seven manufacturing facilities spread across India with modern research laboratories, capabilities in New Drug Development, etc
Read also: Natco Pharma reports multifold rise in net profit to Rs 320.4 crore in Q1
