FDAsafety guidance66% confidence
FDA AP — NAVITRUX (ORIG)
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 NDA220436. Sponsor: AVYXA HOLDINGS. Submission status: AP. Submission type: ORIG. Review priority: STANDARD. Active ingredients: FOSAPREPITANT.
Supporting Context
- Therapeutic area
- Oncology · Antiemetic
- Sub-indication
- General
Related signal: Lupin's ANDA for Fosaprepitant Dimeglumine Receives AP Status from FDA