FDA — authorised 27 May 2011
- Marketing authorisation holder: CUBIST PHARMS
- Status: approved
🇺🇸 Dificid in United States
FDA authorised Dificid on 27 May 2011
Marketing authorisations
FDA — authorised 27 May 2011
- Application: NDA201699
- Marketing authorisation holder: CUBIST PHARMS LLC
- Local brand name: DIFICID
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 January 2020
- Application: NDA213138
- Marketing authorisation holder: CUBIST PHARMS LLC
- Local brand name: DIFICID
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 16 January 2024
- Application: ANDA208443
- Marketing authorisation holder: ACTAVIS LABS FL
- Local brand name: FIDAXOMICIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 January 2026
- Application: ANDA220374
- Marketing authorisation holder: TORRENT
- Local brand name: FIDAXOMICIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 February 2026
- Application: ANDA219559
- Marketing authorisation holder: APOTEX
- Local brand name: FIDAXOMICIN
- Indication: TABLET — ORAL
- Status: approved
Dificid 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 Dificid approved in United States?
Yes. FDA authorised it on 27 May 2011; FDA authorised it on 27 May 2011; FDA authorised it on 24 January 2020.
Who is the marketing authorisation holder for Dificid in United States?
CUBIST PHARMS holds the US marketing authorisation.