FDA — authorised 21 May 2018
- Application: NDA210238
- Marketing authorisation holder: AKARX INC
- Indication: Type 1 - New Molecular Entity
- Status: approved
🇺🇸 Doptelet in United States
FDA authorised Doptelet on 21 May 2018
Marketing authorisations
FDA — authorised 24 July 2025
- Application: NDA219696
- Marketing authorisation holder: AKARX INC
- Indication: Type 3 - New Dosage Form
- Status: approved
The FDA approved Doptelet, a product of AKARX INC, on 24 July 2025, under the application number NDA219696. The approval was granted for a new dosage form of the drug. This approval was made through the standard expedited pathway.
Doptelet in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Cardiovascular approved in United States
Frequently asked questions
Is Doptelet approved in United States?
Yes. FDA authorised it on 21 May 2018; FDA authorised it on 24 July 2025.
Who is the marketing authorisation holder for Doptelet in United States?
AKARX INC holds the US marketing authorisation.