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  1. Drug Approval Package: Marqibo (vinCRIStine sulfate) NDA #202497

    Aug 9, 2012 · Marqibo (vinCRIStine sulfate LIPOSOME injection) Company: Talon Therapeutics, Inc. Application No.: 202497 Approval Date: 08/09/2012 Persons with disabilities having problems …

  2. Marqibo FDA Approval History - Drugs.com

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

  3. FDA Withdraws Approval of MARQIBO - American Society of …

    May 2, 2022 · The U.S. Food and Drug Administration (FDA) has withdrawn approval of MARQIBO (vincristine sulfate liposome injection) after a postmarking clinical trial failed to verify the clinical …

  4. Vincristine liposomal (Marqibo) | HemOnc.org - A Hematology …

    2012-08-09: Accelerated approval for the treatment of adult patients with Philadelphia chromosome-negative (Ph-) acute lymphoblastic leukemia (ALL) in second or greater relapse or whose disease …

  5. To define and describe the accepted indications for Marqibo (vincristine liposome) usage in the treatment of cancer, including FDA approved indications, and off-label indications.

  6. MARQIBO- vincristine sulfate kit - FDA.report

    Marqibo (vinCRIStine sulfate LIPOSOME injection) has different dosage recommendations than vinCRIStine sulfate injection. Verify drug name and dose prior to preparation and administration to …

  7. MARQIBO® (vinCRIStine sulfate LIPOSOME injection)

    The FDA on August 9, 2012 granted accelerated approval for MARQIBO® (vinCRIStine sulfate LIPOSOME injection) for the treatment of adult patients with Philadelphia chromosome-negative (Ph …

  8. 1. INTRODUCTION On August 9, 2012, the Food and Drug Administration (FDA) granted accelerated approval for vincristine sulfate liposome injection (Marqibo®, made by

  9. On May 2, 2022, the FDA withdrew approval of Marqibo after a postmarking clinical trial failed to verify the clinical benefit of the drug. The manufacturer voluntarily withdrew its new drug application and …

  10. FDA Approval for Vincristine Sulfate Liposome - Archive.org

    On August 9, 2012, the Food and Drug Administration (FDA) granted accelerated approval for vincristine sulfate liposome injection (Marqibo®, made by Talon Therapeutics, Inc.) for the treatment of adult …