FDA
- Status: approved
🇺🇸 OFEV® in United States
OFEV® (OFEV®) regulatory status in United States.
Marketing authorisations
FDA
- Application: ANDA215123
- Marketing authorisation holder: EUGIA PHARMA SPECLTS
- Local brand name: NINTEDANIB
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA212732
- Marketing authorisation holder: ACCORD HLTHCARE INC
- Local brand name: NINTEDANIB
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA219371
- Marketing authorisation holder: TEVA PHARMACEUTICALS DEVELOPMENT INC
- Local brand name: NINTEDANIB
- Indication: CAPSULE
- Status: approved
FDA
- Application: ANDA212555
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Local brand name: NINTEDANIB
- Indication: CAPSULE — ORAL
- 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 has authorised it; FDA has authorised it; FDA has authorised it.
Who is the marketing authorisation holder for OFEV® in United States?
Boehringer Ingelheim is the originator. The local marketing authorisation holder may differ — check the official source linked above.