FDA — authorised 2 October 2012
- Application: NDA021290
- Marketing authorisation holder: ACTELION
- Indication: Manufacturing (CMC)
- Status: approved
🇺🇸 Tracleer in United States
FDA authorised Tracleer on 2 October 2012
Marketing authorisations
FDA — authorised 5 September 2017
- Application: NDA209279
- Marketing authorisation holder: ACTELION
- Local brand name: TRACLEER
- Indication: TABLET, FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 26 April 2019
- Application: ANDA205699
- Marketing authorisation holder: PH HEALTH
- Local brand name: BOSENTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 April 2019
- Application: ANDA209324
- Marketing authorisation holder: SUN PHARM
- Local brand name: BOSENTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 April 2019
- Application: ANDA207110
- Marketing authorisation holder: WATSON LABS INC
- Local brand name: BOSENTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 April 2019
- Application: ANDA209742
- Marketing authorisation holder: AMNEAL PHARMS CO
- Local brand name: BOSENTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 April 2019
- Application: ANDA206002
- Marketing authorisation holder: ALVOGEN PINE BROOK
- Local brand name: BOSENTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 April 2019
- Application: ANDA208695
- Marketing authorisation holder: HIKMA
- Local brand name: BOSENTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 January 2020
- Application: ANDA210342
- Marketing authorisation holder: CHARTWELL MOLECULAR
- Local brand name: BOSENTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 January 2020
- Application: ANDA205173
- Marketing authorisation holder: MYLAN
- Local brand name: BOSENTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 January 2020
- Application: ANDA211461
- Marketing authorisation holder: ALEMBIC
- Local brand name: BOSENTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 April 2022
- Application: ANDA207760
- Marketing authorisation holder: ZYDUS PHARMS
- Indication: REMS
- Status: approved
FDA — authorised 5 February 2025
- Application: ANDA213154
- Marketing authorisation holder: NATCO PHARMA LTD
- Local brand name: BOSENTAN
- Indication: TABLET, FOR SUSPENSION — ORAL
- Status: approved
The FDA granted marketing authorisation to NATCO Pharma Ltd for Tracleer on 3 March 2026. This approval was based on a standard expedited pathway application number ANDA213154. The approved indication for Tracleer is under a Risk Evaluation and Mitigation Strategy (REMS).
FDA — authorised 17 February 2026
- Application: ANDA213981
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: BOSENTAN
- Indication: TABLET, FOR SUSPENSION — ORAL
- Status: approved
The FDA approved Tracleer (bosentan) tablets for oral suspension on 17 February 2026. Zydus Pharms received marketing authorisation for this product through a standard expedited pathway. Tracleer is indicated for the treatment of pulmonary arterial hypertension (PAH).
Tracleer in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Immunology approved in United States
Frequently asked questions
Is Tracleer approved in United States?
Yes. FDA authorised it on 2 October 2012; FDA authorised it on 5 September 2017; FDA authorised it on 26 April 2019.
Who is the marketing authorisation holder for Tracleer in United States?
ACTELION holds the US marketing authorisation.