FDA — authorised 15 June 2000
- Application: NDA020715
- Marketing authorisation holder: VERITY
- Local brand name: TRELSTAR
- Indication: INJECTABLE — INTRAMUSCULAR
- Status: approved
🇺🇸 Trelstar in United States
FDA authorised Trelstar on 15 June 2000
Marketing authorisations
FDA — authorised 16 February 2007
- Application: NDA021288
- Marketing authorisation holder: VERITY
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 10 March 2010
- Application: NDA022437
- Marketing authorisation holder: VERITY
- Local brand name: TRELSTAR
- Indication: INJECTABLE — INTRAMUSCULAR
- Status: approved
FDA — authorised 4 October 2019
- Application: NDA208956
- Marketing authorisation holder: AZURITY
- Indication: Labeling
- Status: approved
Trelstar 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 Trelstar approved in United States?
Yes. FDA authorised it on 15 June 2000; FDA authorised it on 16 February 2007; FDA authorised it on 10 March 2010.
Who is the marketing authorisation holder for Trelstar in United States?
VERITY holds the US marketing authorisation.