Trabectedin Approval Status

  • FDA approved: No
  • Generic name: trabectedin
  • Company: Ortho Biotech Products, L.P.
  • Treatment for: Ovarian Cancer

Trabectedin is an investigational cytotoxic antitumor agent used in combination with Doxil (doxorubicin HCl liposome injection) for the treatment of women with relapsed ovarian cancer.

FDA Approval Status for trabectedin

DateArticle
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

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