FDA — authorised 4 August 2010
- Application: NDA021985
- Marketing authorisation holder: LXO IRELAND
- Indication: Labeling
- Status: approved
🇺🇸 Tekturna in United States
FDA authorised Tekturna on 4 August 2010
Marketing authorisations
FDA — authorised 14 November 2017
- Application: NDA210709
- Marketing authorisation holder: NODEN PHARMA
- Local brand name: TEKTURNA
- Indication: CAPSULE, PELLET — ORAL
- Status: approved
FDA — authorised 22 March 2019
- Application: ANDA206665
- Marketing authorisation holder: PH HEALTH
- Local brand name: ALISKIREN HEMIFUMARATE
- Indication: TABLET — ORAL
- Status: approved
Tekturna in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Cardiovascular approved in United States
Frequently asked questions
Is Tekturna approved in United States?
Yes. FDA authorised it on 4 August 2010; FDA authorised it on 14 November 2017; FDA authorised it on 22 March 2019.
Who is the marketing authorisation holder for Tekturna in United States?
LXO IRELAND holds the US marketing authorisation.