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Beleodaq Approval History

  • FDA approved: Yes (First approved July 3rd, 2014)
  • Brand name: Beleodaq
  • Generic name: belinostat
  • Dosage form: Injection
  • Company: Spectrum Pharmaceuticals, Inc.
  • Treatment for: Peripheral T-cell Lymphoma

Beleodaq (belinostat) is a histone deacetylase (HDAC) inhibitor for the treatment of peripheral T-cell lymphoma (PTCL).

Development History and FDA Approval Process for Beleodaq

Jul  3, 2014Approval FDA Approves Beleodaq (belinostat) for Peripheral T-Cell Lymphoma
Feb  6, 2014Spectrum Pharmaceuticals Announces FDA's Acceptance of NDA Filing for Beleodaq (belinostat) for Injection, a novel pan-HDAC inhibitor
Dec 10, 2013New Drug Application for Belinostat in Relapsed or Refractory PTCL Submitted to the FDA

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