FDA — authorised 21 October 2014
- Application: NDA022117
- Marketing authorisation holder: ABBVIE
- Indication: Labeling
- Status: approved
🇺🇸 Saphris in United States
FDA authorised Saphris on 21 October 2014
Marketing authorisations
FDA — authorised 11 October 2019
- Application: NDA212268
- Marketing authorisation holder: HISAMITSU
- Indication: Type 3 - New Dosage Form
- Status: approved
FDA — authorised 10 December 2020
- Application: ANDA206107
- Marketing authorisation holder: SIGMAPHARM LABS LLC
- Status: approved
FDA — authorised 10 December 2020
- Application: ANDA205960
- Marketing authorisation holder: BRECKENRIDGE
- Status: approved
FDA — authorised 27 May 2025
- Application: ANDA206098
- Marketing authorisation holder: ALEMBIC
- Indication: Labeling
- Status: approved
The FDA approved Saphris for labeling indication on 2025-05-27. This approval was granted to ALEMBIC under the standard expedited pathway. The application number for this approval is ANDA206098.
Saphris 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 Saphris approved in United States?
Yes. FDA authorised it on 21 October 2014; FDA authorised it on 11 October 2019; FDA authorised it on 10 December 2020.
Who is the marketing authorisation holder for Saphris in United States?
ABBVIE holds the US marketing authorisation.