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Xenazine Approval History

  • FDA approved: Yes (First approved August 15th, 2008)
  • Brand name: Xenazine
  • Generic name: tetrabenazine
  • Company: Prestwick Pharmaceuticals, Inc.
  • Treatment for: Huntington’s Chorea

Xenazine (tetrabenazine) is a selective and reversible centrally-acting dopamine depleting drug indicated for the treatment of chorea associated with Huntington's disease.

Development History and FDA Approval Process for Xenazine

Aug 15, 2008Approval Xenazine (Tetrabenazine) Approved by FDA for Patients with Chorea Associated with Huntington's Disease
Dec  7, 2007FDA Advisory Committee Votes Unanimously to Recommend Approval of Tetrabenazine for Chorea Associated With Huntington Disease
Mar 31, 2006Prestwick Pharmaceuticals Receives FDA Approvable Letter for Xenazine (Tetrabenazine) for Treatment of Chorea Associated with Huntington's Disease

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