FDAsafety guidance66% confidence
FDA AP — ELOCON (SUPPL)
Source: FDA
Why This Matters
Why this matters: provides agency context on safety guidance that may shape timing or evidence expectations for Organon; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application NDA019543. Sponsor: ORGANON. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: MOMETASONE FUROATE.
Supporting Context
- Therapeutic area
- Contraception · Hormonal
- Sub-indication
- General
Related signal: FDA Accepts Supplement for Implanon by Organon