Horizant 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 History and FDA Approval Process for Horizant
|Jun 7, 2012|| GSK and XenoPort Receive FDA Approval for Horizant for Postherpetic Neuralgia|
|Apr 6, 2011|| 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|
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