FDA — authorised 23 February 2022
- Application: ANDA212025
- Marketing authorisation holder: TP ANDA HOLDINGS
- Status: approved
🇺🇸 Apokyn in United States
FDA authorised Apokyn on 23 February 2022
Marketing authorisations
FDA — authorised 3 February 2025
- Application: NDA214056
- Marketing authorisation holder: MDD US
- Indication: Type 5 - New Formulation or New Manufacturer
- Status: approved
The FDA approved Apokyn, a new formulation or new manufacturer, on 3 February 2025. This approval was granted to MDD US, the marketing authorisation holder, under the standard expedited pathway. The application number for this approval is NDA214056.
Apokyn 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 Apokyn approved in United States?
Yes. FDA authorised it on 23 February 2022; FDA authorised it on 3 February 2025.
Who is the marketing authorisation holder for Apokyn in United States?
TP ANDA HOLDINGS holds the US marketing authorisation.