Uptravi FDA Approval History

Last updated by Judith Stewart, BPharm on Aug 6, 2021.

FDA Approved: Yes (First approved December 21, 2015)
Brand name: Uptravi
Generic name: selexipag
Dosage form: Tablets and Lyophilized Powder for Injection
Company: Johnson & Johnson Innovative Medicine
Treatment for: Pulmonary Arterial Hypertension

Uptravi (selexipag) is a prostacyclin receptor agonist for the treatment of pulmonary arterial hypertension (PAH).

Uptravi is indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) to delay disease progression and reduce the risk of hospitalization for PAH.
Uptravi is administered orally (Uptravi tablets) or by intravenous infusion (Uptravi IV) twice daily.
Uptravi IV is used in patients who are temporarily unable to take oral therapy.
Common adverse reactions include headache, diarrhea, jaw pain, nausea, myalgia, vomiting, pain in extremity, and flushing.

Development timeline for Uptravi

Date	Article
Jul 30, 2021	Approval Uptravi (selexipag) Receives FDA Approval for Intravenous Use in Adult Patients with Pulmonary Arterial Hypertension (PAH)
Dec 22, 2015	Approval FDA Approves Uptravi (selexipag) for Pulmonary Arterial Hypertension
Mar 3, 2015	Actelion's NDA for Selexipag (Uptravi) Accepted by the FDA
Dec 23, 2014	Actelion Submits NDA for Selexipag (Uptravi) in Patients with Pulmonary Arterial Hypertension

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

Drug Status

Availability Prescription only Rx

Pregnancy & Lactation Risk data available

CSA Schedule* Not a controlled drug N/A

Approval History Drug history at FDA

Uptravi FDA Approval History

Development timeline for Uptravi

See also

Further information