FDA — authorised 19 August 2024
- Application: NDA219008
- Marketing authorisation holder: JANSSEN BIOTECH
- Local brand name: LAZCLUZE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 LAZERTINIB MESYLATE in United States
FDA authorised LAZERTINIB MESYLATE on 19 August 2024 · 2 US adverse-event reports
Marketing authorisations
FDA
- 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: 20 April 2025 – 20 April 2026
- Total reports: 2
Most-reported reactions
- Deep Vein Thrombosis — 1 report (50%)
- Pneumonitis — 1 report (50%)
LAZERTINIB MESYLATE in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is LAZERTINIB MESYLATE approved in United States?
Yes. FDA authorised it on 19 August 2024; FDA has authorised it.
Who is the marketing authorisation holder for LAZERTINIB MESYLATE in United States?
JANSSEN BIOTECH holds the US marketing authorisation.