FDA — authorised 24 March 1976
- Application: NDA017630
- Marketing authorisation holder: GE HEALTHCARE
- Indication: Labeling
- Status: approved
🇺🇸 Experimental: Active "I-Reconstruction" Therapy in United States
FDA authorised Experimental: Active "I-Reconstruction" Therapy on 24 March 1976
Marketing authorisations
FDA — authorised 24 November 2004
- Application: NDA021272
- Marketing authorisation holder: UNITED THERAP
- Indication: Efficacy
- Status: approved
FDA — authorised 22 September 2008
- Application: ANDA078098
- Marketing authorisation holder: CURIUM
- Indication: Labeling
- Status: approved
FDA — authorised 14 January 2011
- Application: NDA022454
- Marketing authorisation holder: GE HLTHCARE INC
- Status: approved
FDA — authorised 19 October 2017
- Application: NDA022387
- Marketing authorisation holder: UNITED THERAP
- Indication: Efficacy
- Status: approved
FDA — authorised 11 February 2021
- Application: ANDA211574
- Marketing authorisation holder: ALEMBIC GLOBAL
- Status: approved
FDA — authorised 30 July 2021
- Application: BLA761123
- Marketing authorisation holder: ASTRAZENECA AB
- Status: supplemented
FDA — authorised 30 March 2022
- Application: ANDA213792
- Marketing authorisation holder: CURIUM
- Status: supplemented
Experimental: Active "I-Reconstruction" Therapy in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Infectious Disease approved in United States
Frequently asked questions
Is Experimental: Active "I-Reconstruction" Therapy approved in United States?
Yes. FDA authorised it on 24 March 1976; FDA authorised it on 24 November 2004; FDA authorised it on 22 September 2008.
Who is the marketing authorisation holder for Experimental: Active "I-Reconstruction" Therapy in United States?
GE HEALTHCARE holds the US marketing authorisation.