Federal Register NoticeNeurology

FDA Approval: EPIDIOLEX (CANNABIDIOL) — Type 1 - New Molecular Entity

FDA-NDA210365

Document details

Document type
Federal Register Notice
Issuing body
Office of the Federal Register / NARA
Document ID
FDA-NDA210365
Published
June 10, 2026
Effective date
June 25, 2018
MAC region
National

Summary

Epidiolex, an oral cannabidiol solution, will fall under Medicare Part D for billing purposes. As it is an orphan drug, it may also have specific considerations for reimbursement and coverage. No J-co

Epidiolex gains Medicare Part D coverage impact.

Affected specialty

Neurology alerts →

Source document

https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf

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