FDA — authorised 6 March 2020
- Marketing authorisation holder: RECORDATI RARE
- Status: approved
🇺🇸 Isturisa in United States
FDA authorised Isturisa on 6 March 2020
Marketing authorisations
FDA — authorised 15 April 2025
- Application: NDA212801
- Marketing authorisation holder: RECORDATI RARE
- Indication: Efficacy
- Status: approved
The FDA approved Isturisa for its approved indication on 15 April 2025. The marketing authorisation holder is RECORDATI RARE. The application was submitted under the standard expedited pathway. The approved indication is based on the drug's efficacy.
Isturisa in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Respiratory approved in United States
Frequently asked questions
Is Isturisa approved in United States?
Yes. FDA authorised it on 6 March 2020; FDA authorised it on 15 April 2025.
Who is the marketing authorisation holder for Isturisa in United States?
RECORDATI RARE holds the US marketing authorisation.