FDA — authorised 19 June 2017
- Marketing authorisation holder: MELINTA THERAPEUTICS INC
- Status: approved
🇺🇸 Baxdela in United States
FDA authorised Baxdela on 19 June 2017
Marketing authorisations
FDA — authorised 19 June 2017
- Application: NDA208610
- Marketing authorisation holder: MELINTA
- Local brand name: BAXDELA
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 June 2017
- Application: NDA208611
- Marketing authorisation holder: MELINTA
- Local brand name: BAXDELA
- Indication: POWDER — INTRAVENOUS
- Status: approved
Baxdela 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 Baxdela approved in United States?
Yes. FDA authorised it on 19 June 2017; FDA authorised it on 19 June 2017; FDA authorised it on 19 June 2017.
Who is the marketing authorisation holder for Baxdela in United States?
MELINTA THERAPEUTICS INC holds the US marketing authorisation.