FDA — authorised 30 August 2018
- Marketing authorisation holder: MSD MERCK CO
- Status: approved
🇺🇸 Pifeltro in United States
FDA authorised Pifeltro on 30 August 2018
Marketing authorisations
FDA — authorised 30 August 2018
- Application: NDA210806
- Marketing authorisation holder: MSD MERCK CO
- Local brand name: PIFELTRO
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 April 2026
- Application: NDA216964
- Marketing authorisation holder: MSD
- Local brand name: IDVYNSO
- Indication: TABLET — ORAL
- Status: approved
Pifeltro in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Immunology approved in United States
Frequently asked questions
Is Pifeltro approved in United States?
Yes. FDA authorised it on 30 August 2018; FDA authorised it on 30 August 2018; FDA authorised it on 20 April 2026.
Who is the marketing authorisation holder for Pifeltro in United States?
MSD MERCK CO holds the US marketing authorisation.