FDAsafety guidance72% confidence
FDA AP — CHILDREN'S ZYRTEC HIVES (SUPPL)
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (ild) as adenotonsillar hypertrophy treatment protocols.
Regulatory Analysis
Application NDA022155. Sponsor: KENVUE BRANDS. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: CETIRIZINE HYDROCHLORIDE.
Supporting Context
- Therapeutic area
- ENT · Surgical Intervention
- Sub-indication
- Ild
Related signal: Feasibility Study on IRE System for Adenotonsillar Hypertrophy in Children