FDA — authorised 29 January 1997
- Marketing authorisation holder: PFIZER PHARMS
- Status: approved
🇺🇸 Rezulin in United States
FDA authorised Rezulin on 29 January 1997
Marketing authorisations
FDA — authorised 29 January 1997
- Application: NDA020719
- Marketing authorisation holder: SANKYO
- Local brand name: PRELAY
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 January 1997
- Application: NDA020720
- Marketing authorisation holder: PFIZER PHARMS
- Local brand name: REZULIN
- Indication: TABLET — ORAL
- Status: approved
Rezulin 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 Rezulin approved in United States?
Yes. FDA authorised it on 29 January 1997; FDA authorised it on 29 January 1997; FDA authorised it on 29 January 1997.
Who is the marketing authorisation holder for Rezulin in United States?
PFIZER PHARMS holds the US marketing authorisation.