FDAsafety guidance77% confidence
FDA AP — CHILDREN'S ADVIL-FLAVORED (SUPPL)
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (ild) as Merck; 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
- Infectious Disease · Pneumococcal Vaccine
- Sub-indication
- Ild
Related signal: FDA Approves CAPVAXIVE for At-Risk Children and Adolescents