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Epidiolex Approval Status

  • FDA approved: No
  • Brand name: Epidiolex
  • Generic name: cannabidiol
  • Company: GW Pharmaceuticals plc
  • Treatment for: Lennox-Gastaut Syndrome, Dravet Syndrome

Epidiolex (cannabidiol) is a cannabinoid product in development for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) and Dravet syndrome.

Development Status and FDA Approval Process for Epidiolex

DateArticle
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

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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