← FDA DRUG APPROVALS

FDA NDA · NDA207947

UPTRAVI

selexipag

Sponsor: ACTELION

APPLICATION
NDA207947
TYPE
NDA
ORIGINAL APPROVAL
2015-12-21
LATEST ACTION
2026-05-23
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

UPTRAVI · ReferencePrescription
SELEXIPAG 0.2MG · TABLET · ORAL
UPTRAVI · ReferencePrescription
SELEXIPAG 1.6MG · TABLET · ORAL
UPTRAVI · ReferencePrescription
SELEXIPAG 1.2MG · TABLET · ORAL
UPTRAVI · ReferencePrescription
SELEXIPAG 0.8MG · TABLET · ORAL
UPTRAVI · ReferencePrescription
SELEXIPAG 0.1MG · TABLET · ORAL
UPTRAVI · ReferencePrescription
SELEXIPAG 0.4MG · TABLET · ORAL
UPTRAVI · ReferencePrescription
SELEXIPAG 1.4MG · TABLET · ORAL
UPTRAVI · ReferencePrescription
SELEXIPAG 1MG · TABLET · ORAL
UPTRAVI · ReferencePrescription
SELEXIPAG 0.15MG · TABLET · ORAL
UPTRAVI · ReferencePrescription
SELEXIPAG 0.6MG · TABLET · ORAL

Approval history

2026-05-23Labeling · Supplement 15 · standard — Letter ↗AP
2026-05-23Efficacy · Supplement 14 · priority — Letter ↗AP
2021-10-25Labeling · Supplement 9 · standard — Letter ↗AP
2021-08-19Labeling · Supplement 10 · standard — Label ↗AP
2021-01-30Efficacy · Supplement 8 · standard — Label ↗AP
2019-09-04Labeling · Supplement 7 · standard — Letter ↗AP
2017-12-20Labeling · Supplement 5 · standard — Label ↗AP
2017-09-28Labeling · Supplement 3 · standard — Label ↗AP
2017-07-21Labeling · Supplement 1 · standard — Label ↗AP
2015-12-21Type 1 - New Molecular Entity · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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