FDA — authorised 25 August 2011
- Application: NDA022150
- Marketing authorisation holder: TAKEDA PHARMS USA
- Local brand name: FIRAZYR
- Indication: INJECTABLE — SUBCUTANEOUS
- Status: approved
🇺🇸 Firazyr in United States
FDA authorised Firazyr on 25 August 2011
Marketing authorisations
FDA — authorised 15 July 2019
- Application: ANDA210118
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: ICATIBANT ACETATE
- Indication: INJECTABLE — SUBCUTANEOUS
- Status: approved
FDA — authorised 9 March 2020
- Application: ANDA211021
- Marketing authorisation holder: JIANGSU HANSOH PHARM
- Local brand name: ICATIBANT ACETATE
- Indication: INJECTABLE — SUBCUTANEOUS
- Status: approved
FDA — authorised 18 June 2020
- Application: ANDA208317
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: ICATIBANT ACETATE
- Indication: INJECTABLE — SUBCUTANEOUS
- Status: approved
FDA — authorised 13 July 2020
- Application: ANDA212446
- Marketing authorisation holder: CIPLA
- Local brand name: ICATIBANT ACETATE
- Indication: INJECTABLE — SUBCUTANEOUS
- Status: approved
FDA — authorised 2 September 2020
- Application: ANDA211501
- Marketing authorisation holder: WILSHIRE PHARMS INC
- Local brand name: ICATIBANT ACETATE
- Indication: INJECTABLE — SUBCUTANEOUS
- Status: approved
FDA — authorised 16 December 2020
- Application: ANDA212081
- Marketing authorisation holder: NANG KUANG PHARM CO
- Local brand name: ICATIBANT ACETATE
- Indication: INJECTABLE — SUBCUTANEOUS
- Status: approved
FDA — authorised 21 May 2021
- Application: ANDA213222
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Local brand name: ICATIBANT ACETATE
- Indication: INJECTABLE — SUBCUTANEOUS
- Status: approved
FDA
- Status: approved
Firazyr in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Neuroscience approved in United States
Frequently asked questions
Is Firazyr approved in United States?
Yes. FDA authorised it on 25 August 2011; FDA authorised it on 15 July 2019; FDA authorised it on 9 March 2020.
Who is the marketing authorisation holder for Firazyr in United States?
TAKEDA PHARMS USA holds the US marketing authorisation.