FDAsafety guidance66% confidence
FDA AP — EPIDIOLEX (SUPPL)
Source: FDA
Why This Matters
Why this matters: provides agency context on safety guidance that may shape timing or evidence expectations for Jazz Pharmaceuticals; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application NDA210365. Sponsor: JAZZ PHARMS RES. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: CANNABIDIOL.
Supporting Context
- Therapeutic area
- Neurology · Cannabinoids
- Sub-indication
- General
Related signal: FDA Approves Supplemental Application for Epidiolex by Jazz Pharmaceuticals