Pixuvri Approval Status

  • FDA approved: No
  • Brand name: Pixuvri
  • Generic name: pixantrone
  • Company: Cell Therapeutics, Inc.
  • Treatment for: Non-Hodgkin's Lymphoma

Pixuvri (pixantrone) is a novel major groove binder with an aza-anthracenedione molecular structure in development to treat relapsed or refractory aggressive non-Hodgkin's lymphoma (NHL).

FDA Approval Status for Pixuvri

DateArticle
Jan 30, 2012Cell Therapeutics Withdraws New Drug Application for Pixuvri and Plans to Resubmit in 2012
Jan  3, 2012FDA's Oncologic Drugs Advisory Committee to Review Resubmitted Pixantrone New Drug Application on February 9, 2012
Dec  6, 2011FDA Sets April 24, 2012 as PDUFA Goal Date for Cell Therapeutics' Resubmitted Pixantrone New Drug Application
Oct 25, 2011Cell Therapeutics Resubmits Pixantrone NDA to FDA for Consideration of Accelerated Approval
Jun 14, 2011Cell Therapeutics Completes Type A Meeting With FDA's Division of Oncology Drug Products: Guidance Provided for Resubmission of Pixantrone NDA for Consideration of Accelerated Approval
May 20, 2011FDA Sets Meeting Date in Early June to Discuss Re-submission of Pixantrone NDA for Accelerated Approval
May  3, 2011Cell Therapeutics to¬†Re-submit¬†Pixantrone NDA in Consideration for Accelerated Approval in Accordance with Guidance from FDA's Office of New Drugs
Dec  3, 2010Cell Therapeutics Files Appeal on FDA Decision on New Drug Application (NDA) for Pixantrone to Treat Relapsed/Refractory Aggressive Non-Hodgkin's Lymphoma
Sep 14, 2010Cell Therapeutics to Appeal FDA Decision on New Drug Application (NDA) for Pixantrone to Treat Relapsed/Refractory Aggressive Non-Hodgkin's Lymphoma
Apr  9, 2010CTI Receives Complete Response Letter from the FDA for Pixantrone NDA; CTI to File for Expanded Access for Patients With Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma
Mar 22, 2010CTI Provides Update on FDA Advisory Committee Meeting on Pixantrone for the Treatment of Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma
Mar  2, 2010FDA Sets March 22 for ODAC Meeting to Review CTI's New Drug Application for Pixantrone
Feb  9, 2010FDA Postpones Oncologic Drugs Advisory Committee Meeting to Review Pixantrone Due to Severe Weather Conditions
Dec 17, 2009Cell Therapeutics Announces FDA's Oncologic Drugs Advisory Committee to Review Pixantrone for the Treatment of Relapsed/Refractory Aggressive Non-Hodgkin's Lymphoma, February 10, 2010
Sep  6, 2009FDA Sets Action Date of April 23, 2010 for Review of Pixantrone NDA
Aug 26, 2009FDA Accepts to File Cell Therapeutics' New Drug Application for Pixantrone
Jun 24, 2009Cell Therapeutics Completes Pixantrone NDA Submission and Requests Priority Review
Apr 14, 2009Cell Therapeutics Initiating Rolling NDA Submission For Pixantrone

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