FDA — authorised 12 May 2016
- Application: ANDA203323
- Marketing authorisation holder: SAGENT PHARMS INC
- Indication: Manufacturing (CMC)
- Status: approved
🇺🇸 Arikayce Kit in United States
FDA authorised Arikayce Kit on 12 May 2016
Marketing authorisations
FDA — authorised 28 September 2018
- Application: NDA207356
- Marketing authorisation holder: INSMED INC
- Local brand name: ARIKAYCE KIT
- Indication: SUSPENSION, LIPOSOMAL — INHALATION
- Status: approved
FDA — authorised 13 December 2019
- Application: ANDA204040
- Marketing authorisation holder: AVET LIFESCIENCES
- Indication: Labeling
- Status: approved
FDA — authorised 19 March 2024
- Application: ANDA218146
- Marketing authorisation holder: QILU
- Status: approved
FDA — authorised 28 August 2025
- Application: ANDA205604
- Marketing authorisation holder: FRESENIUS KABI USA
- Indication: Labeling
- Status: approved
The FDA approved FRESENIUS KABI USA's Arikayce Kit on August 28, 2025, for labeling indication. This approval was granted through a standard expedited pathway. Arikayce Kit is a drug product.
Arikayce Kit in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Immunology approved in United States
Frequently asked questions
Is Arikayce Kit approved in United States?
Yes. FDA authorised it on 12 May 2016; FDA authorised it on 28 September 2018; FDA authorised it on 13 December 2019.
Who is the marketing authorisation holder for Arikayce Kit in United States?
SAGENT PHARMS INC holds the US marketing authorisation.