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Onrigin Approval Status

  • FDA approved: No
  • Brand name: Onrigin
  • Generic name: laromustine
  • Dosage form: Injection
  • Company: Vion Pharmaceuticals, Inc.
  • Treatment for: Acute Myeloid Leukemia

Onrigin (laromustine), formerly known as Cloretazine (VNP40101M), is a novel alkylating agent in development for remission induction treatment for patients sixty years of age or older with de novo poor-risk acute myeloid leukemia (AML).

Development Status and FDA Approval Process for Onrigin

DateArticle
Mar  1, 2010Vion Pharmaceuticals Receives Response From FDA on Special Protocol Assessment for Onrigin
Dec 14, 2009Vion Pharmaceuticals Receives Complete Response Letter for Onrigin From The U.S. Food And Drug Administration
Sep  2, 2009Vion Pharmaceuticals Announces Results of the Oncologic Drugs Advisory Committee Meeting for Onrigin
Aug 12, 2009Vion Pharmaceuticals Announces Oncologic Drugs Advisory Committee Meeting for Onrigin
Apr 23, 2009Vion Pharmaceuticals Receives a Standard Review from the FDA for Its New Drug Application for Onrigin
Apr 16, 2009Vion Pharmaceuticals' New Drug Application for Onrigin Accepted For Review by the FDA
Feb 17, 2009Vion Pharmaceuticals Submits New Drug Application for Onrigin

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