FDA — authorised 29 May 1997
- Marketing authorisation holder: PROSTRAKAN INC
- Status: approved
🇺🇸 Fareston in United States
FDA authorised Fareston on 29 May 1997
Marketing authorisations
FDA — authorised 29 May 1997
- Application: NDA020497
- Marketing authorisation holder: KYOWA KIRIN
- Local brand name: FARESTON
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 4 December 2018
- Application: ANDA208813
- Marketing authorisation holder: RISING
- Status: approved
FDA — authorised 18 August 2020
- Application: ANDA212818
- Marketing authorisation holder: MSN
- Status: approved
Fareston in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in United States
Frequently asked questions
Is Fareston approved in United States?
Yes. FDA authorised it on 29 May 1997; FDA authorised it on 29 May 1997; FDA authorised it on 4 December 2018.
Who is the marketing authorisation holder for Fareston in United States?
PROSTRAKAN INC holds the US marketing authorisation.