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Yondelis FDA Approval History

FDA Approved: Yes (First approved October 23, 2015)
Brand name: Yondelis
Generic name: trabectedin
Dosage form: for Injection
Company: Janssen Biotech, Inc.
Treatment for: Soft Tissue Sarcoma

Yondelis (trabectedin) is a cytotoxic antitumor agent for the treatment of unresectable or metastatic liposarcoma or leiomyosarcoma, two common subtypes of soft tissue sarcoma.

Development timeline for Yondelis

Oct 23, 2015Approval FDA Approves Yondelis (trabectedin) for the Treatment of Specific Soft Tissue Sarcomas
Feb  3, 2015U.S. FDA Grants Priority Review for Yondelis (trabectedin) for the Treatment of Patients with Advanced Soft Tissue Sarcoma
Nov 24, 2014Janssen Submits NDA for Yondelis (trabectedin) for Advanced Soft Tissue Sarcoma
Apr 29, 2011Centocor Ortho Biotech Products, L.P. Voluntarily Withdraws NDA for Trabectedin
Sep 10, 2009FDA Issues Complete Response Letter For Trabectedin Combined With Doxil
Nov 20, 2008Ortho Biotech Announces NDA Submission for Trabectedin for the Treatment of Relapsed Ovarian Cancer

Further information

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