EPIDIOLEX

批准信原文要点

NDA 210365/S-030: updates to section 8 Use in Specific Populations and section 13 Nonclinical Toxicology based on the results of study GWTX21066, which was conducted to fulfill a PMR.

批准信原文要点

NDA 210365/S-029: updates to section 6 Adverse Reactions and section 12 Clinical Pharmacology based on results of study GWCP18057, which was conducted to fulfill a PMR.

批准信原文要点

NDA 210365/S-024: updates to section 8 Use in Specific Populations and section 13 Nonclinical Toxicology based on the results of studies GWTX21060 and GWTX21062, which were conducted to fulfill postmarketing requirements (PMRs).

批准信原文要点

We have reviewed your submissions and conclude that the above requirements have been fulfilled.

批准信原文要点

This Prior Approval sNDA provides for revisions to Sections 8.1(Use in Specific Populations; Pregnancy) and 17 (Patient Counseling Information) of the Prescribing Information and to the Medication Guide that provide information about the Pregnancy Surveillance Program. The supplement also provides for revisions to Section 5.1 (Warnings and Precautions; Hepatic Injury) and Section 17 (Patient Counseling Information) pertaining to hepatic injury.

批准信原文要点

This Prior Approval sNDA provides for a clinical labeling update to the Pharmacodynamics subsection (12.2) of the Prescribing Information based on the final report for the following postmarketing requirement listed in the June 25, 2018, approval letter. 3429-17 A thorough QT trial at the maximum tolerable dose of Epidiolex that is feasible (e.g., dosing in the fed state), with appropriate controls (i.e., placebo and positive control).

批准信原文要点

This “Changes Being Effected” sNDA provides for changes to Subsection 2.4 Administration Instructions, of the Prescribing Information, to include language instructing to not use tubes made of polyurethane for administration via feeding tubes.

批准信原文要点

These Prior Approval sNDAs provides for support of a nonclinical labeling update, which include the mouse carcinogenicity results. In addition, these supplements provide for changes to Sections 7 and 12 of the US prescribing information relating to the pharmacokinetic drug-drug interaction between cannabidiol and everolimus identified in the Clinical Study Report for GWCP19195.

批准信原文要点

These Prior Approval sNDAs provides for support of a nonclinical labeling update, which include the mouse carcinogenicity results. In addition, these supplements provide for changes to Sections 7 and 12 of the US prescribing information relating to the pharmacokinetic drug-drug interaction between cannabidiol and everolimus identified in the Clinical Study Report for GWCP19195.

批准信原文要点

This “Changes Being Effected in 30 days” supplemental new drug application provides for the addition of a new size of bottle containing 60 mL of Epidiolex Oral Solution; the currently approved bottle contains 100 mL of this oral solution.

批准信原文要点

This Prior Approval sNDA adds new drug-drug interaction (DDI) information to Section 7.2 (Effect of Epidiolex on Other Drugs) and additional food effect and DDI information to Section 12.3 (Pharmacokinetics) of the Epidiolex labeling.

批准信原文要点

This supplement proposes: To update final Prescribing Information and Medication Guide, Instructions for Use, Carton, and Bottle/Container labels to indicate that Epidiolex (cannabidiol) is no longer a controlled substance.

批准信原文要点

This supplement proposes: To extend the indications for the treatment of seizures associated with Lennox- Gastaut syndrome and Dravet syndrome down to patients 1 year of age and older.

批准信原文要点

This supplement proposes: To support addition of treatment of seizures associated with tuberous sclerosis complex (TSC) in patients 1 vear of aae and older to the Prescribina Information.

批准信原文要点

This new drug application provides for the use of Epidiolex (cannabidiol) 100 mg/mL oral solution for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients two years of age and older.

批准信原文要点

This “Changes Being Effected” supplemental new drug application is submitted in response to the DEA prepublication on September 27, 2018, placing FDA-approved drugs that contain CBD derived from cannabis and no more than percent tetrahydrocannabinols in schedule V of the Controlled Substances Act.