FDAsafety guidance66% confidence
FDA AP — AUVELITY (SUPPL)
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (rare disease) as Sun Pharma; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application NDA215430. Sponsor: AXSOME. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: BUPROPION HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE.
Supporting Context
- Therapeutic area
- Neurology · Cough Suppressant
- Sub-indication
- Rare Disease
Related signal: FDA Accepts ANDA for Dextromethorphan Hydrobromide and Quinidine Sulfate by Sun Pharma