FDA — authorised 25 May 2007
- Application: NDA022064
- Marketing authorisation holder: CHATTEM SANOFI
- Local brand name: XYZAL
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Levocetirizine tablets in United States
FDA authorised Levocetirizine tablets on 25 May 2007 · 10 US adverse-event reports
Marketing authorisations
FDA — authorised 28 January 2008
- Application: NDA022157
- Marketing authorisation holder: CHATTEM SANOFI
- Local brand name: XYZAL
- Indication: SOLUTION — ORAL
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 23 April 2025 – 23 April 2026
- Total reports: 10
Most-reported reactions
- Atrioventricular Block Second Degree — 1 report (10%)
- Blood Pressure Inadequately Controlled — 1 report (10%)
- Coeliac Disease — 1 report (10%)
- Completed Suicide — 1 report (10%)
- Dizziness — 1 report (10%)
- Drug Dose Omission — 1 report (10%)
- Drug Ineffective — 1 report (10%)
- Drug Ineffective For Unapproved Indication — 1 report (10%)
- Dyspnoea — 1 report (10%)
- Eye Swelling — 1 report (10%)
Other Respiratory approved in United States
Frequently asked questions
Is Levocetirizine tablets approved in United States?
Yes. FDA authorised it on 25 May 2007; FDA authorised it on 28 January 2008.
Who is the marketing authorisation holder for Levocetirizine tablets in United States?
CHATTEM SANOFI holds the US marketing authorisation.