FDA — authorised 24 December 1953
- Marketing authorisation holder: ENDO PHARMS
- Status: approved
🇺🇸 Xyosted (Autoinjector) in United States
FDA authorised Xyosted (Autoinjector) on 24 December 1953
Marketing authorisations
FDA — authorised 28 September 2018
- Application: NDA209863
- Marketing authorisation holder: ANTARES PHARMA INC
- Local brand name: XYOSTED (AUTOINJECTOR)
- Indication: SOLUTION — SUBCUTANEOUS
- Status: approved
Xyosted (Autoinjector) 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 Xyosted (Autoinjector) approved in United States?
Yes. FDA authorised it on 24 December 1953; FDA authorised it on 28 September 2018.
Who is the marketing authorisation holder for Xyosted (Autoinjector) in United States?
ENDO PHARMS holds the US marketing authorisation.