Epidiolex Oral Solution and Pretomanid Tablets

• Generic Name: cannabidiol
• Dosage Forms: oral solution
• Other Brand Names: Epidiolex

Epidiolex (cannabidiol) is a prescription medicine used to treat seizures in people with Lennox-Gastaut syndrome or Dravet syndrome.

Epidiolex is for use in adults and children who are at least 2 years old.

Epidiolex is controlled in Schedule V of the Controlled Substances Act. Keep this medicine in a safe place to prevent misuse and abuse.

• Generic Name: pretomanid
• Dosage Forms: tablet
• Other Brand Names:

Limited Population: Pretomanid is an antimycobacterial indicated as part of a combination regimen with bedaquiline and linezolid for the treatment of adults with pulmonary extensively drug resistant (XDR), treatment-intolerant or nonresponsive multidrug-resistant (MDR) tuberculosis (TB). Approval of this indication is based on limited clinical safety and efficacy data. This drug is indicated for use in a limited and specific population of patients.

Pretomanid is not indicated for patients with: drug-sensitive (DS) tuberculosis, latent infection due to Mycobacterium tuberculosis, extrapulmonary infection due to M. tuberculosis, or MDR-TB that is not treatment-intolerant or nonresponsive to standard therapy.

Safety and effectiveness of pretomanid have not been established for its use in combination with drugs other than bedaquiline and linezolid as part of the recommended dosing regimen.