FDA — authorised 3 August 2009
- Marketing authorisation holder: KOWA CO
- Status: approved
🇺🇸 Livalo in United States
FDA authorised Livalo on 3 August 2009
Marketing authorisations
FDA — authorised 3 August 2009
- Application: NDA022363
- Marketing authorisation holder: KOWA CO
- Local brand name: LIVALO
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 February 2017
- Application: ANDA205932
- Marketing authorisation holder: ORIENT PHARMA CO LTD
- Status: approved
FDA — authorised 4 April 2019
- Application: ANDA206070
- Marketing authorisation holder: MYLAN
- Status: approved
FDA — authorised 11 June 2024
- Application: ANDA206047
- Marketing authorisation holder: ZYDUS PHARMS
- Indication: Labeling
- Status: approved
The FDA approved Livalo for labeling indication on June 11, 2024. This approval was granted to ZYDUS PHARMS under the standard expedited pathway. The application number for this approval is ANDA206047.
FDA — authorised 22 July 2024
- Application: ANDA205955
- Marketing authorisation holder: SAWAI USA
- Indication: Labeling
- Status: approved
The FDA approved Livalo for labeling indication on July 22, 2024. This approval was granted to SAWAI USA under the standard expedited pathway. The application number for this approval is ANDA205955.
Livalo in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is Livalo approved in United States?
Yes. FDA authorised it on 3 August 2009; FDA authorised it on 3 August 2009; FDA authorised it on 3 February 2017.
Who is the marketing authorisation holder for Livalo in United States?
KOWA CO holds the US marketing authorisation.