FDA — authorised 28 March 2019
- Application: ANDA208441
- Marketing authorisation holder: MYLAN
- Local brand name: AMBRISENTAN
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Letairis in United States
FDA authorised Letairis on 28 March 2019
Marketing authorisations
FDA — authorised 28 March 2019
- Application: ANDA208252
- Marketing authorisation holder: WATSON LABS INC
- Local brand name: AMBRISENTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 March 2019
- Application: ANDA210058
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: AMBRISENTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 March 2019
- Application: ANDA210784
- Marketing authorisation holder: SUN PHARM
- Local brand name: AMBRISENTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 April 2019
- Application: ANDA208354
- Marketing authorisation holder: SIGMAPHARM LABS LLC
- Local brand name: AMBRISENTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 April 2019
- Application: ANDA209509
- Marketing authorisation holder: PH HEALTH
- Local brand name: AMBRISENTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 April 2019
- Application: ANDA210715
- Marketing authorisation holder: CIPLA
- Local brand name: AMBRISENTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 May 2022
- Application: ANDA210701
- Marketing authorisation holder: APOTEX
- Local brand name: AMBRISENTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 July 2022
- Application: ANDA216531
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: AMBRISENTAN
- Indication: TABLET — ORAL
- Status: approved
FDA
- Status: approved
Letairis 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 Letairis approved in United States?
Yes. FDA authorised it on 28 March 2019; FDA authorised it on 28 March 2019; FDA authorised it on 28 March 2019.
Who is the marketing authorisation holder for Letairis in United States?
MYLAN holds the US marketing authorisation.