FDA — authorised 30 January 2009
- Marketing authorisation holder: TAKEDA PHARMS USA
- Status: approved
🇺🇸 Dexilant in United States
FDA authorised Dexilant on 30 January 2009
Marketing authorisations
FDA — authorised 1 October 2020
- Application: ANDA202294
- Marketing authorisation holder: PH HEALTH
- Indication: Labeling
- Status: approved
FDA — authorised 27 November 2020
- Application: NDA022287
- Marketing authorisation holder: TAKEDA PHARMS USA
- Indication: Labeling
- Status: approved
FDA — authorised 19 January 2024
- Application: ANDA205205
- Marketing authorisation holder: MYLAN
- Status: approved
FDA — authorised 14 August 2025
- Application: ANDA202666
- Marketing authorisation holder: TWI PHARMS
- Indication: Labeling
- Status: approved
The FDA approved Dexilant for marketing in the United States on 14 August 2025. The approval was granted to TWI PHARMS under the standard expedited pathway. Dexilant is a medication used for its approved indication, as stated in the labelling.
FDA — authorised 12 November 2025
- Application: ANDA219115
- Marketing authorisation holder: ALEMBIC
- Status: approved
Dexilant in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Pain approved in United States
Frequently asked questions
Is Dexilant approved in United States?
Yes. FDA authorised it on 30 January 2009; FDA authorised it on 1 October 2020; FDA authorised it on 27 November 2020.
Who is the marketing authorisation holder for Dexilant in United States?
TAKEDA PHARMS USA holds the US marketing authorisation.