FDA — authorised 29 April 2016
- Application: NDA208289
- Marketing authorisation holder: EXELA PHARMA
- Local brand name: AKOVAZ
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
🇺🇸 Akovaz in United States
FDA authorised Akovaz on 29 April 2016
Marketing authorisations
FDA — authorised 14 June 2021
- Application: ANDA214579
- Marketing authorisation holder: EUGIA PHARMA
- Status: approved
FDA — authorised 31 March 2022
- Application: ANDA212932
- Marketing authorisation holder: AMNEAL
- Indication: Labeling
- Status: approved
FDA — authorised 21 April 2022
- Application: ANDA215825
- Marketing authorisation holder: XIROMED
- Status: approved
FDA — authorised 9 March 2023
- Application: ANDA214528
- Marketing authorisation holder: SAGENT PHARMS INC
- Status: approved
FDA — authorised 18 July 2024
- Application: ANDA219050
- Marketing authorisation holder: CAPLIN
- Status: approved
FDA
- Status: approved
Akovaz 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 Akovaz approved in United States?
Yes. FDA authorised it on 29 April 2016; FDA authorised it on 14 June 2021; FDA authorised it on 31 March 2022.
Who is the marketing authorisation holder for Akovaz in United States?
EXELA PHARMA holds the US marketing authorisation.