🇺🇸 Actos in United States

FDA authorised Actos on 15 July 1999

Marketing authorisations

FDA — authorised 15 July 1999

  • Application: NDA021073
  • Marketing authorisation holder: TAKEDA PHARMS USA
  • Status: supplemented

FDA

  • Status: approved

FDA

  • Application: ANDA076799
  • Marketing authorisation holder: ALPHAPHARM
  • Local brand name: PIOGLITAZONE
  • Indication: TABLET — ORAL
  • Status: approved

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Actos in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Other approved in United States

Frequently asked questions

Is Actos approved in United States?

Yes. FDA authorised it on 15 July 1999; FDA has authorised it; FDA has authorised it.

Who is the marketing authorisation holder for Actos in United States?

TAKEDA PHARMS USA holds the US marketing authorisation.