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

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

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.