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Epidiolex FDA 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: Seizures associated with Lennox-Gastaut Syndrome, Dravet syndrome, or Tuberous Sclerosis Complex

Epidiolex (cannabidiol) is a prescription pharmaceutical formulation of highly-purified, marijuana plant-derived cannabidiol (CBD) indicated for the treatment of seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, or tuberous sclerosis complex.

Development Timeline for Epidiolex

DateArticle
Aug  3, 2020Approval FDA Approves Epidiolex (cannabidiol) Oral Solution to Treat Seizures Associated with Tuberous Sclerosis Complex
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

Further information

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