FDAsafety guidance66% confidence
FDA AP — CHILDREN'S ADVIL-FLAVORED (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 NDA020589. Sponsor: HALEON US HOLDINGS. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: IBUPROFEN.
Supporting Context
- Therapeutic area
- Respiratory · Bronchodilator
- Sub-indication
- General
Related signal: Lupin Inc. Submits ANDA for Revefenacin to FDA