FDAsafety guidance77% confidence
FDA AP — ADRENALIN (SUPPL)
Source: FDA
Why This Matters
Why this matters: provides agency context on safety guidance that may shape timing or evidence expectations for Lupin; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application NDA204640. Sponsor: PH HEALTH. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: EPINEPHRINE.
Supporting Context
- Therapeutic area
- Women's Health · Contraceptive
- Sub-indication
- General
Related signal: Lupin's ANDA201446 for Levonorgestrel Receives Standard Review Status