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Marqibo Approval History

FDA Approved: Yes (First approved August 9, 2012)
Brand name: Marqibo
Generic name: vincristine sulfate liposomes
Dosage form: Injection
Previous Name: Onco TCS
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).

Development History and FDA Approval Process 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
May 21, 2004INEX and Enzon Announce FDA Acceptance of Onco TCS New Drug Application
Mar 15, 2004INEX and Enzon Complete the Filing of a New Drug Application for Onco TCS

Further information

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