FDA — authorised 8 May 2020
- Marketing authorisation holder: LOXO ONCOLOGY INC
- Status: approved
🇺🇸 Retevmo in United States
FDA authorised Retevmo on 8 May 2020
Marketing authorisations
FDA — authorised 8 May 2020
- Application: NDA213246
- Marketing authorisation holder: ELI LILLY AND CO
- Local brand name: RETEVMO
- Indication: CAPSULE — ORAL
- Status: approved
The FDA approved Retevmo, a medication developed by ELI LILLY AND CO, on 18 December 2024. The approval was granted through a standard expedited pathway. The approved indication for Retevmo is listed in its labelling, but the specific indication is not reported in the available data.
FDA — authorised 10 April 2024
- Application: NDA218160
- Marketing authorisation holder: ELI LILLY AND CO
- Local brand name: RETEVMO
- Indication: TABLET — ORAL
- Status: approved
The FDA approved Retevmo, a drug developed by ELI LILLY AND CO, for its approved indication on 27 September 2024. The application number for this approval is NDA218160. Retevmo was approved through the standard expedited pathway.
Retevmo 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 Retevmo approved in United States?
Yes. FDA authorised it on 8 May 2020; FDA authorised it on 8 May 2020; FDA authorised it on 10 April 2024.
Who is the marketing authorisation holder for Retevmo in United States?
LOXO ONCOLOGY INC holds the US marketing authorisation.