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Horizant Approval History

  • FDA approved: Yes (First approved April 6th, 2011)
  • Brand name: Horizant
  • Generic name: gabapentin enacarbil
  • Dosage form: Extended Release Tablets
  • Previous name: Solzira
  • Company: GlaxoSmithKline and XenoPort, Inc.
  • Treatment for: Restless Legs Syndrome, Postherpetic Neuralgia

Horizant (gabapentin enacarbil) is a gabapentin prodrug indicated for the once-daily treatment of restless legs syndrome and postherpetic neuralgia.

Development History and FDA Approval Process for Horizant

DateArticle
Jun  7, 2012Approval GSK and XenoPort Receive FDA Approval for Horizant for Postherpetic Neuralgia
Apr  6, 2011Approval GlaxoSmithKline and XenoPort Receive FDA Approval for Horizant
Nov  8, 2010GlaxoSmithKline and XenoPort Respond to FDA on Horizant for RLS
Feb 19, 2010Depomed Comments on DM-1796 Pre-NDA Meeting and Horizant Complete Response Letter
Feb 18, 2010GlaxoSmithKline and XenoPort Receive FDA Complete Response Letter for Horizant (GSK1838262/XP13512) for RLS
Feb 10, 2010XenoPort Announces Extension of the Horizant PDUFA Date to February 11, 2010
Feb  4, 2010XenoPort Announces Horizant as Brand Name for XP13512
Mar 16, 2009XenoPort to Receive $23 Million in Milestone Payments Associated With FDA Acceptance of Solzira NDA
Jan  9, 2009GSK and XenoPort Resubmit New Drug Application for Solzira in Restless Legs Syndrome
Nov 10, 2008GSK and XenoPort Announce Plans to Withdraw and Resubmit New Drug Application Requesting Approval of Solzira for Restless Legs Syndrome
Sep 16, 2008GSK and XenoPort Announce Submission of NDA Requesting FDA Approval of Solzira for Restless Legs Syndrome

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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