FDA — authorised 16 February 2001
- Marketing authorisation holder: NOVARTIS
- Status: approved
🇺🇸 Foradil in United States
FDA authorised Foradil on 16 February 2001
Marketing authorisations
FDA — authorised 11 May 2007
- Application: NDA022007
- Marketing authorisation holder: VIATRIS SPECIALTY
- Indication: Type 3 - New Dosage Form
- Status: approved
FDA — authorised 29 March 2019
- Application: NDA210595
- Marketing authorisation holder: AZURITY
- Indication: Type 4 - New Combination
- Status: approved
FDA — authorised 22 August 2022
- Application: ANDA215053
- Marketing authorisation holder: LUPIN
- Status: approved
FDA — authorised 16 July 2024
- Application: ANDA215883
- Marketing authorisation holder: MANKIND PHARMA
- Indication: Manufacturing (CMC)
- Status: approved
The FDA granted marketing authorisation for Foradil to Mankind Pharma on 16 July 2024. This authorisation was approved under the standard expedited pathway. The approved indication for Foradil is Manufacturing (CMC).
FDA — authorised 30 January 2025
- Application: ANDA215907
- Marketing authorisation holder: DR REDDYS
- Status: approved
Foradil 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 Foradil approved in United States?
Yes. FDA authorised it on 16 February 2001; FDA authorised it on 11 May 2007; FDA authorised it on 29 March 2019.
Who is the marketing authorisation holder for Foradil in United States?
NOVARTIS holds the US marketing authorisation.