bosentan
bosentan is listed in the FDA National Drug Code directory with 7 NDC codes, marketed under brand names including bosentan, Tracleer. Available dosage forms: tablet, for suspension, tablet, film coated.
Drug Details
- Generic Name
- bosentan
- Brand Names
- bosentan, Tracleer
- Application Number
- ANDA213981
- Sponsor
- Zydus Lifesciences Limited
- NDC Codes
- 7
- Dosage Forms
- TABLET, FOR SUSPENSION, TABLET, FILM COATED
- Routes
- ORAL
- Active Ingredients
- BOSENTAN
Indications and Usage
1 INDICATIONS AND USAGE Bosentan is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1): in adults to improve exercise ability and to decrease clinical worsening. Studies establishing effectiveness included predominantly patients with WHO Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (60%), PAH associated with connective tissue diseases (21%), and PAH associated with congenital heart disease with left-to-right shunts (18%) [see Clinical Studies (14.1)] . in pediatric patients aged 3 years and older with idiopathic or congenital PAH to improve pulmonary vascular resistance (PVR), which is expected to result in an improvement in exercise ability. Bosentan is an endothelin receptor antagonist indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1): in adults to improve exercise ability and to decrease clinical worsening. Studies establishing effectiveness included predominantly patients with WHO Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (60%), PAH associated with connective tissue diseases (21%), and PAH associated with congenital heart disease with left-to-right shunts (18%) (1). in pediatric patients aged 3 years and older with idiopathic or congenital PAH to improve pulmonary vascular resistance (PVR), which is expected to result in an improvement in exercise ability (1).