FDA — authorised 15 January 1974
- Marketing authorisation holder: PAR STERILE PRODUCTS
- Status: approved
🇺🇸 Ryanodex in United States
FDA authorised Ryanodex on 15 January 1974
Marketing authorisations
FDA — authorised 12 July 2001
- Application: NDA018264
- Marketing authorisation holder: PH HEALTH
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 24 October 2005
- Application: ANDA076686
- Marketing authorisation holder: ELITE LABS INC
- Status: approved
FDA — authorised 22 July 2014
- Application: NDA205579
- Marketing authorisation holder: EAGLE PHARMS
- Local brand name: RYANODEX
- Indication: FOR SUSPENSION — INTRAVENOUS
- Status: approved
FDA — authorised 27 May 2015
- Application: ANDA078378
- Marketing authorisation holder: USWM
- Indication: Labeling
- Status: approved
FDA — authorised 18 April 2025
- Application: ANDA204762
- Marketing authorisation holder: HIKMA
- Indication: Labeling
- Status: approved
The FDA approved Ryanodex, manufactured by HIKMA, on 18 April 2025. This approval was granted through a standard expedited pathway. The approved indication for Ryanodex is listed in its labelling, but the specific indication is not specified in the available data.
Ryanodex in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is Ryanodex approved in United States?
Yes. FDA authorised it on 15 January 1974; FDA authorised it on 12 July 2001; FDA authorised it on 24 October 2005.
Who is the marketing authorisation holder for Ryanodex in United States?
PAR STERILE PRODUCTS holds the US marketing authorisation.