Treats acute hyperammonemia due to N-acetylglutamate synthase (NAGS) deficiency. ANDA 213729, held by Novitium Pharma. Carglumic Acid.
As of Nov 15, 2026, ANDA 213729 (Carglumic Acid), held by Novitium Pharma, was first approved by FDA on Oct 13, 2021, with 2 approved supplements 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 are 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 |
|---|---|---|---|
| Oct 13, 2021 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Carglumic Acid200MG · tablet, for suspension;oral | Carglumic Acid | Rx |
| May 30, 2024 | Supplement 8Labeling · Standard review | Approved | None posted |
| Jun 22, 2022 | Supplement 1Manufacturing | Approved | None posted |
| Oct 13, 2021 | Original application | 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
