FDA — authorised 18 March 2022
- Marketing authorisation holder: MARINUS PHARMA INC
- Status: approved
🇺🇸 Ztalmy in United States
FDA authorised Ztalmy on 18 March 2022
Marketing authorisations
FDA — authorised 9 November 2022
- Application: NDA215904
- Marketing authorisation holder: IMMEDICA PHARMA
- Indication: Labeling
- Status: approved
Ztalmy in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Neuroscience approved in United States
Frequently asked questions
Is Ztalmy approved in United States?
Yes. FDA authorised it on 18 March 2022; FDA authorised it on 9 November 2022.
Who is the marketing authorisation holder for Ztalmy in United States?
MARINUS PHARMA INC holds the US marketing authorisation.