FDAsafety guidance66% confidence
FDA AP — ZYRTEC ALLERGY (SUPPL)
Source: FDA
Why This Matters
Why this matters: provides agency context on safety guidance that may shape timing or evidence expectations for Macleods Pharmaceuticals; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application NDA022578. Sponsor: KENVUE BRANDS. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: CETIRIZINE HYDROCHLORIDE.
Supporting Context
- Therapeutic area
- Allergy · Antihistamine
- Sub-indication
- General
Related signal: FDA Grants AP Status for Levocetirizine Dihydrochloride ANDA205564