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Natco Pharma gets tentative approval for Yondelis generic

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Trabectedin, sold under the brand name Yondelis, is an antitumor chemotherapy medication for the treatment of advanced soft-tissue sarcoma and ovarian cancer.

The US Food and Drug Administration has granted tentative approval to Natco Pharma's 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.

Natco Pharma is a vertically integrated and R&D focused pharmaceutical company engaged in developing, manufacturing and marketing of finished dosage formulations ("FDF") and active pharmaceutical ingredients ("APIs"). It markets and distributes products in over 40 countries.

 

On a consolidated basis, net profit of Natco Pharma rose 327.20% to Rs 320.40 crore on 115.60% increase in net sales to Rs 884.60 crore in Q1 June 2022 over Q1 June 2021.

Shares of Natco Pharma fell 0.57% to Rs 651.30 on Wednesday, 17 August 2022.

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First Published: Aug 18 2022 | 8:38 AM IST

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