FDA — authorised 6 May 2013
- Application: NDA050794
- Marketing authorisation holder: BRISTOL-MYERS
- Indication: Manufacturing (CMC)
- Status: approved
🇺🇸 Vidaza in United States
FDA authorised Vidaza on 6 May 2013
Marketing authorisations
FDA — authorised 21 September 2020
- Application: ANDA207234
- Marketing authorisation holder: NATCO PHARMA LTD
- Indication: Labeling
- Status: approved
FDA — authorised 17 May 2021
- Application: NDA214120
- Marketing authorisation holder: BRISTOL
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 3 February 2022
- Application: ANDA211549
- Marketing authorisation holder: AMNEAL
- Status: approved
FDA — authorised 16 May 2024
- Application: ANDA212580
- Marketing authorisation holder: MSN LABS PVT LTD
- Status: approved
Vidaza 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 Vidaza approved in United States?
Yes. FDA authorised it on 6 May 2013; FDA authorised it on 21 September 2020; FDA authorised it on 17 May 2021.
Who is the marketing authorisation holder for Vidaza in United States?
BRISTOL-MYERS holds the US marketing authorisation.