FDAsafety guidance83% confidence
FDA AP — AUVELITY (SUPPL)
Source: FDA
Why This Matters
Why this matters: illustrates how regulators handled a comparable safety guidance decision relevant to COVAC-2.
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
- Infectious Disease · COVID-19
- Sub-indication
- General
Related signal: COVAC-2 Vaccine Shows Safety and Immunogenicity as COVID-19 Booster in Phase 1 Trial
Source
FDA document
View source