FDA — authorised 21 December 2017
- Application: NDA208843
- Marketing authorisation holder: THERAVIA
- Local brand name: SIKLOS
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Hydroxycarbamide in United States
FDA authorised Hydroxycarbamide on 21 December 2017
Marketing authorisation
Hydroxycarbamide 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 Hydroxycarbamide approved in United States?
Yes. FDA authorised it on 21 December 2017.
Who is the marketing authorisation holder for Hydroxycarbamide in United States?
THERAVIA holds the US marketing authorisation.