FDA — authorised 20 February 1953
- Marketing authorisation holder: HOSPIRA
- Status: approved
🇺🇸 Infuvite Pediatric in United States
FDA authorised Infuvite Pediatric on 20 February 1953
Marketing authorisations
FDA — authorised 21 February 2001
- Application: NDA021265
- Marketing authorisation holder: SANDOZ CANADA INC
- Local brand name: INFUVITE PEDIATRIC
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 15 July 2016
- Application: NDA203324
- Marketing authorisation holder: GLAUKOS
- Indication: Efficacy
- Status: approved
FDA — authorised 17 October 2025
- Application: NDA219910
- Marketing authorisation holder: GLAUKOS
- Indication: Type 5 - New Formulation or New Manufacturer
- Status: approved
The FDA approved Infuvite Pediatric, a new formulation or new manufacturer of a drug, on 2025-10-17. The marketing authorisation holder is GLAUKOS. This approval was granted under the standard expedited pathway.
Infuvite Pediatric 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 Infuvite Pediatric approved in United States?
Yes. FDA authorised it on 20 February 1953; FDA authorised it on 21 February 2001; FDA authorised it on 15 July 2016.
Who is the marketing authorisation holder for Infuvite Pediatric in United States?
HOSPIRA holds the US marketing authorisation.