FDA — authorised 11 April 2022
- Application: ANDA213210
- Marketing authorisation holder: DR REDDYS
- Local brand name: REGADENOSON
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
🇺🇸 Pharmacologic Stress Agent in United States
FDA authorised Pharmacologic Stress Agent on 11 April 2022
Marketing authorisations
FDA — authorised 11 April 2022
- Application: ANDA207604
- Marketing authorisation holder: APOTEX
- Local brand name: REGADENOSON
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 11 April 2022
- Application: ANDA213236
- Marketing authorisation holder: ACCORD HLTHCARE
- Local brand name: REGADENOSON
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 11 April 2022
- Application: ANDA212806
- Marketing authorisation holder: MEITHEAL
- Local brand name: REGADENOSON
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 12 July 2022
- Application: ANDA207320
- Marketing authorisation holder: GLAND
- Local brand name: REGADENOSON
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 31 August 2022
- Application: ANDA214349
- Marketing authorisation holder: HOSPIRA
- Local brand name: REGADENOSON
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 26 October 2022
- Application: ANDA216437
- Marketing authorisation holder: EUGIA PHARMA
- Local brand name: REGADENOSON
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 2 February 2023
- Application: ANDA215827
- Marketing authorisation holder: HIKMA
- Local brand name: REGADENOSON
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 23 May 2023
- Application: ANDA217455
- Marketing authorisation holder: BAXTER HLTHCARE CORP
- Local brand name: REGADENOSON
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 22 August 2024
- Application: ANDA218054
- Marketing authorisation holder: INDIES PHARMA
- Local brand name: REGADENOSON
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
Pharmacologic Stress Agent in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is Pharmacologic Stress Agent approved in United States?
Yes. FDA authorised it on 11 April 2022; FDA authorised it on 11 April 2022; FDA authorised it on 11 April 2022.
Who is the marketing authorisation holder for Pharmacologic Stress Agent in United States?
DR REDDYS holds the US marketing authorisation.