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Potiga Approval History

  • FDA approved: Yes (First approved June 10th, 2011)
  • Brand name: Potiga
  • Generic name: ezogabine
  • Dosage form: Tablets
  • Company: GlaxoSmithKline and Valeant Pharmaceuticals International
  • Treatment for: Seizures

Potiga (ezogabine) is a potassium channel opener indicated for the adjunctive treatment of adults with partial-onset seizures.

Development History and FDA Approval Process for Potiga

Jun 13, 2011Approval Valeant and GlaxoSmithKline Announce U.S. FDA Approval of Potiga (ezogabine)
Apr 18, 2011Regulatory Update - GSK and Valeant Respond to FDA on Ezogabine
Dec  2, 2010GSK and Valeant Announce Receipt of U.S. FDA Complete Response Letter for ezogabine
Aug 12, 2010Ezogabine, an Investigational Anti-Epileptic Drug, Receives Positive Vote from FDA Advisory Committee
Dec 30, 2009FDA Accepts NDA Filing for Retigabine

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