FDA — authorised 29 December 1989
- Application: NDA019726
- Marketing authorisation holder: TERSERA
- Local brand name: ZOLADEX
- Indication: IMPLANT — IMPLANTATION
- Status: approved
🇺🇸 Zoladex in United States
FDA authorised Zoladex on 29 December 1989
Marketing authorisations
FDA — authorised 31 August 2009
- Application: NDA020578
- Marketing authorisation holder: TERSERA
- Indication: Labeling
- Status: approved
Zoladex 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 Zoladex approved in United States?
Yes. FDA authorised it on 29 December 1989; FDA authorised it on 31 August 2009.
Who is the marketing authorisation holder for Zoladex in United States?
TERSERA holds the US marketing authorisation.