FDAsafety guidance66% confidence
FDA AP — NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL AND FERROUS FUMARATE (SUPPL)
Source: FDA
Why This Matters
Why this matters: provides agency context on safety guidance that may shape timing or evidence expectations for Mundipharma; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application ANDA205049. Sponsor: XIROMED. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: ETHINYL ESTRADIOL, NORETHINDRONE ACETATE.
Supporting Context
- Therapeutic area
- Infectious Disease · Antifungal
- Sub-indication
- General
Related signal: FDA Accepts Supplement Application for REZZAYO (Rezafungin Acetate)