Treats acute hyperammonemia due to N-acetylglutamate synthase (NAGS) deficiency. ANDA 213395, held by Navinta LLC. Carglumic Acid.
As of Nov 15, 2026, ANDA 213395 (Carglumic Acid), held by Navinta LLC, was first approved by FDA on Jun 22, 2022, with 1 approved supplement and 0 published complete response letters.
Carglumic acid tablets for oral suspension is a carbamoyl phosphate synthetase 1 (CPS 1) activator indicated in pediatric and adult patients as: Adjunctive therapy to standard of care for the treatment of acute hyperammonemia due to N-acetylglutamate synthase (NAGS) deficiency. Maintenance therapy for the treatment of chronic hyperammonemia due to NAGS deficiency. 1.1 Acute and Chronic Hyperammonemia due to N-acetylglutamate Synthase (NAGS) Deficiency Carglumic acid tablets for oral suspension is indicated in adult and pediatric patients as: Adjunctive therapy to standard of care for the treatment of acute hyperammonemia due to NAGS deficiency.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 22, 2022 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Carglumic Acid200MG · tablet, for suspension;oral | Carglumic Acid | Rx |
| May 30, 2024 | Supplement 2Labeling · Standard review | Approved | None posted |
| Jun 22, 2022 | Original application | Approved | None posted |
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
