Approvable designations
Approvable designations
• Sitaxsentan (Thelin, Encysive Pharmaceuticals) for the treatment of pulmonary arterial hypertension
Fast-track designations
Priority review
• Infliximab (Remicade, Centocor) for pediatric Crohn's disease
Orphan drug designations
• Cell-permeable peptide (AM-111, Auris Medical) for acute sensorineural hearing loss