FDA — authorised 30 September 2022
- Application: NDA214801
- Marketing authorisation holder: TAIHO ONCOLOGY
- Local brand name: LYTGOBI
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Lytgobi in United States
FDA authorised Lytgobi on 30 September 2022
Marketing authorisations
FDA
- Status: approved
Lytgobi 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 Lytgobi approved in United States?
Yes. FDA authorised it on 30 September 2022; FDA has authorised it.
Who is the marketing authorisation holder for Lytgobi in United States?
TAIHO ONCOLOGY holds the US marketing authorisation.