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Epidiolex Approval History

  • FDA approved: Yes (First approved June 25, 2018)
  • Brand name: Epidiolex
  • Generic name: cannabidiol
  • Dosage form: Oral Solution
  • Company: GW Pharmaceuticals plc
  • Treatment for: Lennox-Gastaut Syndrome, Dravet Syndrome

Epidiolex (cannabidiol) is a prescription pharmaceutical formulation of highly-purified, marijuana plant-derived cannabidiol (CBD) for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients two years of age or older.

Development History and FDA Approval Process for Epidiolex

DateArticle
Jun 25, 2018Approval FDA Approves Epidiolex (cannabidiol) to Treat Lennox-Gastaut Syndrome and Dravet Syndrome
Apr 19, 2018Unanimous Positive Result of FDA Advisory Committee Meeting for First Plant-Based Pharmaceutical Cannabidiol Treatment for Seizures in Patients with Two Rare, Severe Forms of Epilepsy
Jan 24, 2018GW Pharmaceuticals and its U.S. Subsidiary Greenwich Biosciences Announce Publication of Landmark Epidiolex (cannabidiol) Study in The Lancet
Dec 28, 2017GW Pharmaceuticals Announces Acceptance of NDA Filing for Epidiolex (cannabidiol) in the treatment of Lennox-Gastaut syndrome and Dravet syndrome
Oct 30, 2017GW Pharmaceuticals and its U.S. Subsidiary Greenwich Biosciences Completes Rolling NDA Submission to U.S. FDA for Epidiolex (cannabidiol) in the Treatment of Lennox-Gastaut Syndrome and Dravet Syndrome
Sep 26, 2016GW Pharmaceuticals Announces Second Positive Phase 3 Pivotal Trial for Epidiolex (cannabidiol) in the Treatment of Lennox-Gastaut Syndrome
Jun 27, 2016GW Pharmaceuticals Announces Positive Phase 3 Pivotal Trial Results for Epidiolex (cannabidiol) in the Treatment of Lennox-Gastaut Syndrome
Mar 14, 2016GW Pharmaceuticals Announces Positive Phase 3 Pivotal Study Results for Epidiolex (cannabidiol)
Jan  8, 2015GW Pharmaceuticals Provides Update on Epidiolex Program in Treatment-Resistant Childhood Epilepsies
Oct 30, 2014GW Pharmaceuticals Commences Phase 2/3 Clinical Trial of Epidiolex for Dravet Syndrome
May  7, 2014GW Pharmaceuticals Receives IND from FDA for Phase 2/3 Clinical Trial of Epidiolex
Sep 18, 2013GW Pharmaceuticals Begins Phase I Trial of Epilepsy Drug

Further information

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