FDA — authorised 23 March 2017
- Marketing authorisation holder: SHIONOGI INC
- Status: approved
🇺🇸 Symproic in United States
FDA authorised Symproic on 23 March 2017
Marketing authorisations
FDA — authorised 1 August 2017
- Application: NDA208854
- Marketing authorisation holder: BDSI
- Indication: Labeling
- Status: approved
Symproic in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is Symproic approved in United States?
Yes. FDA authorised it on 23 March 2017; FDA authorised it on 1 August 2017.
Who is the marketing authorisation holder for Symproic in United States?
SHIONOGI INC holds the US marketing authorisation.