Selexipag
Selexipag is listed in the FDA National Drug Code directory with 39 NDC codes, marketed under brand names including UPTRAVI, Selexipag, Selexipag TITRATION PACK. Available dosage forms: tablet, coated, powder, tablet, film coated, kit, capsule.
Drug Details
- Generic Name
- Selexipag
- Brand Names
- UPTRAVI, Selexipag, Selexipag TITRATION PACK, UPTRAVI Titration Pack
- Application Number
- NDA207947
- Sponsor
- Actelion Pharmaceuticals US, Inc.
- NDC Codes
- 39
- Dosage Forms
- TABLET, COATED, POWDER, TABLET, FILM COATED, KIT, CAPSULE, INJECTION, POWDER, FOR SOLUTION
- Routes
- ORAL, INTRAVENOUS
- Active Ingredients
- SELEXIPAG
Indications and Usage
1 INDICATIONS AND USAGE UPTRAVI is a prostacyclin receptor agonist indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I): In adults to delay disease progression and reduce the risk of hospitalization for PAH. ( 1.1 ) In pediatric patients aged 2 years and older. UPTRAVI reduces NT-proBNP and is expected to delay disease progression and reduce the risk of hospitalization for PAH. ( 1.1 ) 1.1 Pulmonary Arterial Hypertension Adult Patients UPTRAVI is indicated for the treatment of pulmonary arterial hypertension in adults (PAH, WHO Group I) to delay disease progression and reduce the risk of hospitalization for PAH. Effectiveness of UPTRAVI tablets was established in a long-term study in adult PAH patients with WHO Functional Class II–III symptoms. Patients had idiopathic and heritable PAH (58%), PAH associated with connective tissue disease (29%), PAH associated with congenital heart disease with repaired shunts (10%) [see Clinical Studies (14.1) ] . Pediatric Patients UPTRAVI is indicated for the treatment of PAH (WHO Group I) in pediatric patients aged two years and older. UPTRAVI reduces NT-proBNP and is expected to delay disease progression and reduce the risk of hospitalization for PAH.