FDA — authorised 18 October 2013
- Marketing authorisation holder: ACTELION PHARMS LTD
- Status: approved
🇺🇸 Opsumit in United States
FDA authorised Opsumit on 18 October 2013
Marketing authorisations
FDA — authorised 18 October 2013
- Application: NDA204410
- Marketing authorisation holder: ACTELION
- Local brand name: OPSUMIT
- Indication: TABLET — ORAL
- Status: approved
The FDA approved Opsumit, manufactured by Actelion, for the treatment of Pulmonary Arterial Hypertension (PAH). This approval was granted under a Risk Evaluation and Mitigation Strategy (REMS) to ensure safe use of the medication. The REMS program aims to minimize the risk of adverse events associated with Opsumit.
FDA — authorised 5 August 2024
- Application: ANDA211107
- Marketing authorisation holder: TORRENT
- Local brand name: MACITENTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 April 2025
- Application: NDA218490
- Marketing authorisation holder: ACTELION
- Indication: REMS
- Status: approved
The FDA approved Opsumit, manufactured by Actelion, for the treatment of Pulmonary Arterial Hypertension (PAH). This approval was granted under a Risk Evaluation and Mitigation Strategy (REMS) to ensure safe use of the medication. The REMS program aims to minimize the risk of adverse events associated with Opsumit.
FDA — authorised 18 August 2025
- Application: ANDA211128
- Marketing authorisation holder: ALEMBIC
- Local brand name: MACITENTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 August 2025
- Application: ANDA211136
- Marketing authorisation holder: MSN
- Local brand name: MACITENTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 August 2025
- Application: ANDA211123
- Marketing authorisation holder: SUN PHARM
- Local brand name: MACITENTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 November 2025
- Application: ANDA211120
- Marketing authorisation holder: LAURUS
- Local brand name: MACITENTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 December 2025
- Application: ANDA211026
- Marketing authorisation holder: SEASONS BIOTECH
- Local brand name: MACITENTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 December 2025
- Application: ANDA211161
- Marketing authorisation holder: MYLAN
- Local brand name: MACITENTAN
- Indication: TABLET — ORAL
- Status: approved
Opsumit 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 Opsumit approved in United States?
Yes. FDA authorised it on 18 October 2013; FDA authorised it on 18 October 2013; FDA authorised it on 5 August 2024.
Who is the marketing authorisation holder for Opsumit in United States?
ACTELION PHARMS LTD holds the US marketing authorisation.