macitentan
macitentan is listed in the FDA National Drug Code directory with 6 NDC codes, marketed under brand names including Macitentan, OPSUMIT, macitentan. Available dosage form: tablet, film coated.
Drug Details
- Generic Name
- macitentan
- Brand Names
- Macitentan, OPSUMIT, macitentan
- Application Number
- ANDA211026
- Sponsor
- Novugen Pharma (USA) LLC
- NDC Codes
- 6
- Dosage Forms
- TABLET, FILM COATED
- Routes
- ORAL
- Active Ingredients
- MACITENTAN
Indications and Usage
1 INDICATIONS AND USAGE OPSUMIT is an endothelin receptor antagonist (ERA) indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) in adults to reduce the risks of disease progression and hospitalization for PAH ( 1.1 ). 1.1 Pulmonary Arterial Hypertension OPSUMIT is an endothelin receptor antagonist (ERA) indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) in adults to reduce the risks of disease progression and hospitalization for PAH. Effectiveness was established in a long-term study in PAH patients with predominantly WHO Functional Class II–III symptoms treated for an average of 2 years. Patients had idiopathic and heritable PAH (57%), PAH caused by connective tissue disorders (31%), and PAH caused by congenital heart disease with repaired shunts (8%) [see Clinical Studies (14.1) ] .