FDA — authorised 15 October 2014
- Marketing authorisation holder: BOEHRINGER INGELHEIM
- Status: approved
🇺🇸 Ofev in United States
FDA authorised Ofev on 15 October 2014
Marketing authorisations
FDA — authorised 16 June 2016
- Application: NDA205832
- Marketing authorisation holder: BOEHRINGER INGELHEIM
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 2 April 2026
- Application: ANDA219819
- Marketing authorisation holder: DEXCEL
- Status: approved
FDA — authorised 2 April 2026
- Application: ANDA219227
- Marketing authorisation holder: APOTEX
- Status: approved
FDA — authorised 2 April 2026
- Application: ANDA219283
- Marketing authorisation holder: DR REDDYS
- Status: approved
FDA — authorised 2 April 2026
- Application: ANDA212609
- Marketing authorisation holder: CIPLA
- Status: approved
Ofev 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 Ofev approved in United States?
Yes. FDA authorised it on 15 October 2014; FDA authorised it on 16 June 2016; FDA authorised it on 2 April 2026.
Who is the marketing authorisation holder for Ofev in United States?
BOEHRINGER INGELHEIM holds the US marketing authorisation.