ambrisentan
ambrisentan is listed in the FDA National Drug Code directory with 8 NDC codes, marketed under brand names including ambrisentan, Ambrisentan. Available dosage form: tablet, film coated.
Drug Details
- Generic Name
- ambrisentan
- Brand Names
- ambrisentan, Ambrisentan
- Application Number
- ANDA216531
- Sponsor
- A-S Medication Solutions
- NDC Codes
- 8
- Dosage Forms
- TABLET, FILM COATED
- Routes
- ORAL
- Active Ingredients
- AMBRISENTAN
Indications and Usage
1 INDICATIONS AND USAGE Letairis is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) in adult patients: To improve exercise ability and delay clinical worsening. In combination with tadalafil to reduce the risks of disease progression and hospitalization for worsening PAH, and to improve exercise ability [see Clinical Studies (14.2) ]. Studies establishing effectiveness included predominantly patients with WHO Functional Class II–III symptoms and etiologies of idiopathic or heritable PAH (60%) or PAH associated with connective tissue diseases (34%). Letairis is an endothelin receptor antagonist indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) in adult patients: To improve exercise ability and delay clinical worsening. In combination with tadalafil to reduce the risks of disease progression and hospitalization for worsening PAH, and to improve exercise ability. Studies establishing effectiveness included trials predominantly in patients with WHO Functional Class II–III symptoms and etiologies of idiopathic or heritable PAH (60%) or PAH associated with connective tissue diseases (34%) ( 1 ).