FDA — authorised 18 March 2010
- Application: NDA022562
- Marketing authorisation holder: RECORDATI RARE
- Local brand name: CARBAGLU
- Indication: TABLET, FOR SUSPENSION — ORAL
- Status: approved
🇺🇸 Carbaglu in United States
FDA authorised Carbaglu on 18 March 2010
Marketing authorisations
FDA — authorised 13 October 2021
- Application: ANDA213729
- Marketing authorisation holder: NOVITIUM PHARMA
- Local brand name: CARGLUMIC ACID
- Indication: TABLET, FOR SUSPENSION — ORAL
- Status: approved
The FDA approved Carbaglu, a medication, for its labelled indication on 2024-05-30. The marketing authorisation holder is NOVITIUM PHARMA. The application was submitted under the standard expedited pathway.
FDA — authorised 22 June 2022
- Application: ANDA213395
- Marketing authorisation holder: NAVINTA LLC
- Local brand name: CARGLUMIC ACID
- Indication: TABLET, FOR SUSPENSION — ORAL
- Status: approved
Carbaglu in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Gastroenterology approved in United States
Frequently asked questions
Is Carbaglu approved in United States?
Yes. FDA authorised it on 18 March 2010; FDA authorised it on 13 October 2021; FDA authorised it on 22 June 2022.
Who is the marketing authorisation holder for Carbaglu in United States?
RECORDATI RARE holds the US marketing authorisation.