Selexipag
Drug Details
- Generic Name
- Selexipag
- Brand Names
- Selexipag, UPTRAVI, UPTRAVI Titration Pack, Selexipag TITRATION PACK
- Application Number
- ANDA214302
- Sponsor
- Zydus Lifesciences Limited
- NDC Codes
- 37
- Dosage Forms
- TABLET, FILM COATED, CAPSULE, POWDER, KIT, TABLET, COATED, INJECTION, POWDER, FOR SOLUTION
- Routes
- ORAL, INTRAVENOUS
- Active Ingredients
- SELEXIPAG
Indications and Usage
1 INDICATIONS AND USAGE Selexipag tablets are a prostacyclin receptor agonist indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) to delay disease progression and reduce the risk of hospitalization for PAH. ( 1.1 ) 1.1 Pulmonary Arterial Hypertension Selexipag tablets are indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) to delay disease progression and reduce the risk of hospitalization for PAH. Effectiveness of selexipag tablets was established in a long-term study in 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 )] .