FDA — authorised 1 February 2013
- Marketing authorisation holder: HYPERION THERAP INC
- Status: approved
🇺🇸 Ravicti in United States
FDA authorised Ravicti on 1 February 2013
Marketing authorisations
FDA — authorised 1 February 2013
- Application: NDA203284
- Marketing authorisation holder: HORIZON THERAP US
- Local brand name: RAVICTI
- Indication: LIQUID — ORAL
- Status: approved
FDA — authorised 2 December 2021
- Application: ANDA205742
- Marketing authorisation holder: PH HEALTH
- Status: approved
FDA — authorised 15 April 2026
- Application: ANDA219540
- Marketing authorisation holder: MSN
- Status: approved
FDA — authorised 15 April 2026
- Application: ANDA220313
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: GLYCEROL PHENYLBUTYRATE
- Indication: LIQUID
- Status: approved
The FDA approved Ravicti (Glycerol Phenylbutyrate) for the treatment of urea cycle disorders in liquid form. This approval was granted to Aurobindo Pharma under the standard expedited pathway. The application number for this approval is ANDA220313.
FDA — authorised 15 April 2026
- Application: ANDA218738
- Marketing authorisation holder: TEVA PHARMS INC
- Local brand name: GLYCEROL PHENYLBUTYRATE
- Indication: LIQUID — ORAL
- Status: approved
The FDA approved Ravicti, an oral liquid formulation of Glycerol Phenylbutyrate, for the treatment of patients with urea cycle disorders. This approval was granted to Teva Pharms Inc on 15 April 2026, following a standard review pathway. The approval is based on the submission of an Abbreviated New Drug Application (ANDA) with application number ANDA218738.
FDA
- Application: ANDA215139
- Marketing authorisation holder: ANNORA PHARMA
- Local brand name: GLYCEROL PHENYLBUTYRATE
- Indication: LIQUID — ORAL
- Status: approved
Ravicti 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 Ravicti approved in United States?
Yes. FDA authorised it on 1 February 2013; FDA authorised it on 1 February 2013; FDA authorised it on 2 December 2021.
Who is the marketing authorisation holder for Ravicti in United States?
HYPERION THERAP INC holds the US marketing authorisation.