Horizant FDA Approval History
FDA Approved: Yes (First approved April 6, 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 timeline for Horizant
| Date | Article |
|---|
| Jun 7, 2012 | Approval GSK and XenoPort Receive FDA Approval for Horizant for Postherpetic Neuralgia |
| Apr 6, 2011 | Approval GlaxoSmithKline and XenoPort Receive FDA Approval for Horizant |
| Nov 8, 2010 | GlaxoSmithKline and XenoPort Respond to FDA on Horizant for RLS |
| Feb 19, 2010 | Depomed Comments on DM-1796 Pre-NDA Meeting and Horizant Complete Response Letter |
| Feb 18, 2010 | GlaxoSmithKline and XenoPort Receive FDA Complete Response Letter for Horizant (GSK1838262/XP13512) for RLS |
| Feb 10, 2010 | XenoPort Announces Extension of the Horizant PDUFA Date to February 11, 2010 |
| Feb 4, 2010 | XenoPort Announces Horizant as Brand Name for XP13512 |
| Mar 16, 2009 | XenoPort to Receive $23 Million in Milestone Payments Associated With FDA Acceptance of Solzira NDA |
| Jan 9, 2009 | GSK and XenoPort Resubmit New Drug Application for Solzira in Restless Legs Syndrome |
| Nov 10, 2008 | GSK and XenoPort Announce Plans to Withdraw and Resubmit New Drug Application Requesting Approval of Solzira for Restless Legs Syndrome |
| Sep 16, 2008 | GSK and XenoPort Announce Submission of NDA Requesting FDA Approval of Solzira for Restless Legs Syndrome |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Medical Disclaimer
