Manages urea cycle disorders (UCDs). NDA 203284, held by Horizon Therap US. Glycerol Phenylbutyrate.
As of Nov 13, 2026, NDA 203284 (Ravicti), held by Horizon Therap US, was first approved by FDA on Feb 1, 2013, with 8 approved supplements and 0 published complete response letters.
RAVICTI is indicated for use as a nitrogen-binding agent for chronic management of patients with urea cycle disorders (UCDs) who cannot be managed by dietary protein restriction and/or amino acid supplementation alone. RAVICTI must be used with dietary protein restriction and, in some cases, dietary supplements (e.g., essential amino acids, arginine, citrulline, protein-free calorie supplements). Limitations of Use: RAVICTI is not indicated for the treatment of acute hyperammonemia in patients with UCDs because more rapidly acting interventions are essential to reduce plasma ammonia levels.
| Oct 4, 2019 | Supplement 11Efficacy (new indication or use) · Standard review | Approved | |
| Dec 21, 2018 | Supplement 10Efficacy (new indication or use) · Standard review | Approved | |
| Apr 28, 2017 | Supplement 5Efficacy (new indication or use) · Standard review | Approved | |
| Sep 8, 2016 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | |
| Feb 1, 2013 | Original applicationNew active ingredient · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ravicti1.1GM/ML · liquid;oral | Glycerol Phenylbutyrate | RxReference drug |
| Sep 3, 2021 | Supplement 12Labeling · Standard review | Approved | |
| Oct 4, 2019 | Supplement 11Efficacy (new indication or use) · Standard review | Approved | |
| Dec 21, 2018 | Supplement 10Efficacy (new indication or use) · Standard review | Approved | |
| Apr 28, 2017 | Supplement 5Efficacy (new indication or use) · Standard review | Approved | |
| Sep 8, 2016 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | |
| Jul 27, 2015 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Jan 5, 2015 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Jun 24, 2014 | Supplement 1Labeling · Standard review | Approved | |
| Feb 1, 2013 | Original applicationNew active ingredient · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
