Carbaglu

Treats acute hyperammonemia due to N-acetylglutamate synthase (NAGS) deficiency. NDA 22562, held by Recordati Rare. Carglumic Acid.

As of Nov 14, 2026, NDA 22562 (Carbaglu), held by Recordati Rare, was first approved by FDA on Mar 18, 2010, with 11 approved supplements and 0 published complete response letters.

First approved: Mar 18, 2010
Review: Priority
Supplements approved: 11
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

1. INDICATIONS AND USAGE CARBAGLU 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. Adjunctive therapy to standard of care for the treatment of acute hyperammonemia due to propionic acidemia (PA) or methylmalonic acidemia (MMA). 1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 12 submissions below


Jan 22, 2021	Supplement 8Efficacy (new indication or use) · Priority review	Approved	Label Letter
Jan 22, 2021	Supplement 9Efficacy (new indication or use) · Priority review	Approved	Label Letter
Mar 18, 2010	Original applicationNew molecular entity · Priority review	Approved	Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Carbaglu200MG · tablet, for suspension;oral	Carglumic Acid	RxReference drug

All 12 submissions, including labeling and manufacturing supplements


Jan 19, 2024	Supplement 14Labeling · Standard review	Approved	Letter Label
Aug 5, 2021	Supplement 13Labeling · Standard review	Approved	Label Letter
Jan 22, 2021	Supplement 8Efficacy (new indication or use) · Priority review	Approved	Label Letter
Jan 22, 2021	Supplement 9Efficacy (new indication or use) · Priority review	Approved	Label Letter
Aug 26, 2020	Supplement 12Labeling · Standard review	Approved	Letter
Dec 23, 2019	Supplement 11Labeling · Standard review	Approved	Label Letter
Nov 16, 2017	Supplement 5Labeling · Standard review	Approved	Label Letter
Nov 5, 2015	Supplement 4Manufacturing · Priority review	Approved	None posted
Jan 23, 2014	Supplement 3Manufacturing · Priority review	Approved	None posted
Aug 5, 2013	Supplement 2Labeling · Standard review	Approved	Letter Label
Jul 22, 2013	Supplement 1Manufacturing · Priority review	Approved	None posted
Mar 18, 2010	Original applicationNew molecular entity · Priority review	Approved	Review Letter Label

Identifiers

Application: NDA 22562
Drugs@FDA: Overview at FDA
Company: Recordati Rare Diseases

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