FDA — authorised 23 December 2020
- Application: NDA213006
- Marketing authorisation holder: SUMITOMO PHARMA AM
- Local brand name: GEMTESA
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Gemtesa in United States
FDA authorised Gemtesa on 23 December 2020
Marketing authorisations
FDA
- Status: approved
Gemtesa in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is Gemtesa approved in United States?
Yes. FDA authorised it on 23 December 2020; FDA has authorised it.
Who is the marketing authorisation holder for Gemtesa in United States?
SUMITOMO PHARMA AM holds the US marketing authorisation.