ARTICLE | Company News

SkyePharma slips after Flutiform complete response

January 22, 2010 1:25 AM UTC

SkyePharma plc (LSE:SKP) fell 12.25p (13%) to 84p on Thursday after FDA issued a complete response letter for an NDA for Flutiform to treat persistent asthma in patients ages 12 and older. The company said FDA raised a number of issues that would involve additional clinical work, including additional data on dosing. SkyePharma said in September that it is unlikely Flutiform will be approved in the U.S. before 2H11. ...