FDA — authorised 16 September 2014
- Marketing authorisation holder: ASTRAZENECA PHARMS
- Status: approved
🇺🇸 Movantik in United States
FDA authorised Movantik on 16 September 2014
Marketing authorisations
FDA — authorised 16 September 2014
- Application: NDA204760
- Marketing authorisation holder: AVERITAS
- Local brand name: MOVANTIK
- Indication: TABLET — ORAL
- Status: approved
Movantik in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in United States
Frequently asked questions
Is Movantik approved in United States?
Yes. FDA authorised it on 16 September 2014; FDA authorised it on 16 September 2014.
Who is the marketing authorisation holder for Movantik in United States?
ASTRAZENECA PHARMS holds the US marketing authorisation.