FDA — authorised 16 November 2014
- Application: NDA202379
- Marketing authorisation holder: JANSSEN BIOTECH
- Indication: Manufacturing (CMC)
- Status: approved
🇺🇸 Abiraterone Acetate in United States
FDA authorised Abiraterone Acetate on 16 November 2014
Marketing authorisations
FDA — authorised 31 October 2018
- Application: ANDA208453
- Marketing authorisation holder: APOTEX
- Status: approved
FDA — authorised 31 October 2018
- Application: ANDA208339
- Marketing authorisation holder: HIKMA
- Local brand name: ABIRATERONE ACETATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 January 2019
- Application: ANDA208327
- Marketing authorisation holder: AMNEAL PHARMS
- Local brand name: ABIRATERONE ACETATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 February 2019
- Application: ANDA208371
- Marketing authorisation holder: RISING
- Local brand name: ABIRATERONE ACETATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 February 2019
- Application: ANDA208380
- Marketing authorisation holder: WOCKHARDT BIO AG
- Local brand name: ABIRATERONE ACETATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 July 2019
- Application: ANDA210686
- Marketing authorisation holder: MSN
- Local brand name: ABIRATERONE ACETATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 September 2019
- Application: ANDA212462
- Marketing authorisation holder: QILU
- Local brand name: ABIRATERONE ACETATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 April 2021
- Application: ANDA209227
- Marketing authorisation holder: GLENMARK SPECLT
- Indication: Labeling
- Status: approved
FDA — authorised 20 December 2021
- Application: ANDA208416
- Marketing authorisation holder: DR REDDYS
- Indication: Labeling
- Status: approved
FDA — authorised 26 January 2023
- Application: ANDA210726
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: ABIRATERONE ACETATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 December 2025
- Application: NDA216793
- Marketing authorisation holder: JANSSEN BIOTECH
- Indication: Efficacy
- Status: approved
The FDA approved Abiraterone Acetate for its approved indication. This approval was granted to Janssen Biotech following a standard expedited pathway. The application number for this approval is NDA216793.
FDA
- Marketing authorisation holder: DR REDDYS
- Status: approved
Abiraterone Acetate 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 Abiraterone Acetate approved in United States?
Yes. FDA authorised it on 16 November 2014; FDA authorised it on 31 October 2018; FDA authorised it on 31 October 2018.
Who is the marketing authorisation holder for Abiraterone Acetate in United States?
JANSSEN BIOTECH holds the US marketing authorisation.