FDA — authorised 5 January 2024
- Application: NDA217424
- Marketing authorisation holder: LNHC
- Local brand name: ZELSUVMI
- Indication: GEL — TOPICAL
- Status: approved
🇺🇸 BERDAZIMER SODIUM in United States
FDA authorised BERDAZIMER SODIUM on 5 January 2024
Marketing authorisations
FDA
- Status: approved
BERDAZIMER SODIUM 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 BERDAZIMER SODIUM approved in United States?
Yes. FDA authorised it on 5 January 2024; FDA has authorised it.
Who is the marketing authorisation holder for BERDAZIMER SODIUM in United States?
LNHC holds the US marketing authorisation.