FDA — authorised 2 September 2005
- Application: NDA020873
- Marketing authorisation holder: SANDOZ
- Indication: Labeling
- Status: approved
🇺🇸 Angiomax in United States
FDA authorised Angiomax on 2 September 2005
Marketing authorisations
FDA — authorised 14 July 2015
- Application: ANDA090811
- Marketing authorisation holder: HOSPIRA
- Local brand name: BIVALIRUDIN
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 14 July 2015
- Application: ANDA090816
- Marketing authorisation holder: HOSPIRA
- Local brand name: BIVALIRUDIN
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 28 October 2016
- Application: ANDA090189
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: BIVALIRUDIN
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 26 May 2017
- Application: ANDA201577
- Marketing authorisation holder: DR REDDYS
- Local brand name: BIVALIRUDIN
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 21 December 2017
- Application: NDA208374
- Marketing authorisation holder: BAXTER HLTHCARE CORP
- Local brand name: BIVALIRUDIN IN 0.9% SODIUM CHLORIDE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 1 June 2018
- Application: ANDA202471
- Marketing authorisation holder: MYLAN INSTITUTIONAL
- Local brand name: BIVALIRUDIN
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 16 July 2018
- Application: ANDA091602
- Marketing authorisation holder: MEITHEAL
- Local brand name: BIVALIRUDIN
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 27 July 2018
- Application: ANDA205962
- Marketing authorisation holder: EUGIA PHARMA
- Local brand name: BIVALIRUDIN
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 23 October 2019
- Application: ANDA210031
- Marketing authorisation holder: SHUANGCHENG
- Local brand name: BIVALIRUDIN
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 28 May 2021
- Application: ANDA213078
- Marketing authorisation holder: SLATE RUN PHARMA
- Status: approved
FDA — authorised 9 May 2023
- Application: NDA211215
- Marketing authorisation holder: MAIA PHARMS INC
- Indication: Labeling
- Status: approved
FDA — authorised 18 February 2025
- Application: ANDA206551
- Marketing authorisation holder: ACCORD HLTHCARE
- Indication: Labeling
- Status: approved
The FDA approved Angiomax for its labelled indication on 18 February 2025. The marketing authorisation was granted to ACCORD HLTHCARE through a standard expedited pathway. The application number for this approval is ANDA206551.
FDA
- Application: ANDA091206
- Marketing authorisation holder: PLIVA HRVATSKA DOO
- Local brand name: BIVALIRUDIN
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
Angiomax in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Cardiovascular approved in United States
Frequently asked questions
Is Angiomax approved in United States?
Yes. FDA authorised it on 2 September 2005; FDA authorised it on 14 July 2015; FDA authorised it on 14 July 2015.
Who is the marketing authorisation holder for Angiomax in United States?
SANDOZ holds the US marketing authorisation.