Actelion Receives Complete Response Letter for Tracleer

Actelion will have to get FDA approval of a risk evaluation and mitigation strategy (REMS) for Tracleer before the agency approves the drug’s sNDA, which seeks an expanded indication to treat patients with less severe pulmonary arterial hypertension. The company filed its sNDA for Tracleer (bosentan), an oral dual endothelin receptor antagonist, in August 2007 and submitted a REMS for it last September, according to a company statement. The approval requirement was sent in a complete response letter to Actelion.
Drug Industry Daily