FDA — authorised 5 March 2014
- Marketing authorisation holder: ENDO PHARMS INC
- Status: approved
🇺🇸 Aveed in United States
FDA authorised Aveed on 5 March 2014
Marketing authorisations
FDA — authorised 24 January 2018
- Application: NDA022219
- Marketing authorisation holder: ENDO OPERATIONS
- Indication: Labeling
- Status: approved
FDA — authorised 11 July 2025
- Application: NDA208088
- Marketing authorisation holder: VERITY
- Indication: Labeling
- Status: approved
The FDA approved Aveed, a testosterone undecanoate injection, for labeling indication on 11 July 2025. The marketing authorisation holder is VERITY. Aveed was approved through the standard expedited pathway. The application number is NDA208088.
FDA — authorised 11 July 2025
- Application: NDA213953
- Marketing authorisation holder: MARIUS
- Indication: Labeling
- Status: approved
The FDA approved Aveed, a testosterone undecanoate injection, for labeling indication on July 11, 2025. The marketing authorization was granted to MARIUS, the holder of the New Drug Application (NDA) 213953. Aveed was approved through the standard expedited pathway.
FDA — authorised 12 September 2025
- Application: NDA206089
- Marketing authorisation holder: TOLMAR
- Indication: Labeling
- Status: approved
The FDA approved Aveed, a testosterone undecanoate injection, for labeling indication on 12 September 2025. The marketing authorisation holder is TOLMAR. Aveed was approved through the standard expedited pathway. The application number is NDA206089.
Aveed 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 Aveed approved in United States?
Yes. FDA authorised it on 5 March 2014; FDA authorised it on 24 January 2018; FDA authorised it on 11 July 2025.
Who is the marketing authorisation holder for Aveed in United States?
ENDO PHARMS INC holds the US marketing authorisation.