FDA — authorised 23 May 2014
- Marketing authorisation holder: DURATA THERAPS INTL
- Status: approved
🇺🇸 Dalvance in United States
FDA authorised Dalvance on 23 May 2014
Marketing authorisations
FDA — authorised 23 May 2014
- Application: NDA021883
- Marketing authorisation holder: ABBVIE
- Local brand name: DALVANCE
- Indication: POWDER — INTRAVENOUS
- Status: approved
FDA — authorised 23 October 2025
- Application: ANDA219465
- Marketing authorisation holder: TEVA PHARMS INC
- Status: approved
FDA — authorised 10 November 2025
- Application: ANDA217591
- Marketing authorisation holder: FRESENIUS KABI USA
- Status: approved
FDA — authorised 26 November 2025
- Application: ANDA218929
- Marketing authorisation holder: KINDOS
- Status: approved
FDA — authorised 26 February 2026
- Application: ANDA218602
- Marketing authorisation holder: LONG GROVE PHARMS
- Status: approved
Dalvance in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Infectious Disease approved in United States
Frequently asked questions
Is Dalvance approved in United States?
Yes. FDA authorised it on 23 May 2014; FDA authorised it on 23 May 2014; FDA authorised it on 23 October 2025.
Who is the marketing authorisation holder for Dalvance in United States?
DURATA THERAPS INTL holds the US marketing authorisation.