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Marqibo Approval History

  • FDA approved: Yes (First approved August 9th, 2012)
  • Brand name: Marqibo
  • Generic name: vincristine sulfate liposomes
  • Company: Talon Therapeutics Inc.
  • Treatment for: Acute Lymphoblastic Leukemia

Marqibo (vincristine sulfate liposome injection) is a vinca alkaloid indicated for the treatment of adult patients with Philadelphia chromosome-negative (Ph-) acute lymphoblastic leukemia (ALL).

FDA Approval History for Marqibo

DateArticle
Aug  9, 2012Approval FDA Approves Marqibo for Philadelphia Chromosome Negative Acute Lymphoblastic Leukemia
May  7, 2012Talon Therapeutics Receives Notification of Three Month PDUFA Date Extension for Marqibo
Apr  2, 2012Tekmira Provides Update on Licensed Product Candidate, Marqibo
Jan 19, 2005FDA Issues Not Approvable Letter for Marqibo
Dec  1, 2004INEX and ENZON Announce ODAC Does Not Support Accelerated Approval for Cancer Drug Marqibo
Sep 27, 2004INEX and Enzon Announce Marqibo to be Reviewed by FDA's Oncologic Drugs Advisory Committee

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.

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