Treats acute hyperammonemia and associated encephalopathy. NDA 215025, held by Maia Pharms Inc. Sodium Benzoate; Sodium Phenylacetate.
As of Nov 14, 2026, NDA 215025 (Sodium Phenylacetate And Sodium Benzoate), held by Maia Pharms Inc, was first approved by FDA on Jun 10, 2021, with 0 approved supplements and 0 published complete response letters.
Sodium Phenylacetate and Sodium Benzoate Injection is indicated as adjunctive therapy in pediatric and adult patients for the treatment of acute hyperammonemia and associated encephalopathy in patients with deficiencies in enzymes of the urea cycle. During acute hyperammonemic episodes, arginine supplementation, caloric supplementation, dietary protein restriction, hemodialysis, and other ammonia lowering therapies should be considered.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 10, 2021 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Sodium Phenylacetate And Sodium Benzoate10%;10% (2GM/20ML;2GM/20ML) · solution;intravenous | Sodium Benzoate; Sodium Phenylacetate | RxReference drug |
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
