FDA — authorised 27 June 2013
- Application: NDA021073
- Marketing authorisation holder: TAKEDA PHARMS USA
- Indication: Manufacturing (CMC)
- Status: approved
🇺🇸 Actos in United States
FDA authorised Actos on 27 June 2013
Marketing authorisations
FDA — authorised 21 July 2015
- Application: ANDA200268
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Indication: Labeling
- Status: approved
FDA — authorised 26 November 2018
- Application: ANDA077210
- Marketing authorisation holder: TEVA PHARMS USA
- Indication: Labeling
- Status: approved
FDA — authorised 1 July 2019
- Application: NDA022426
- Marketing authorisation holder: TAKEDA PHARMS USA
- Indication: Labeling
- Status: approved
FDA — authorised 21 February 2020
- Application: ANDA202001
- Marketing authorisation holder: TORRENT PHARMS LTD
- Indication: Labeling
- Status: approved
Actos in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is Actos approved in United States?
Yes. FDA authorised it on 27 June 2013; FDA authorised it on 21 July 2015; FDA authorised it on 26 November 2018.
Who is the marketing authorisation holder for Actos in United States?
TAKEDA PHARMS USA holds the US marketing authorisation.