Review Decision On sNDA For Actelion’s Tracleer Awaits Finalized REMS
An FDA “complete response” letter says the REMS the firm submitted in September 2008 must be finalized and approved before the agency can act on the expanded indication.
An FDA “complete response” letter says the REMS the firm submitted in September 2008 must be finalized and approved before the agency can act on the expanded indication.