News|Articles|May 1, 2006

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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

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