BioCentury
ARTICLE | Company News

FDA approves Shire's Xiidra

July 12, 2016 1:01 AM UTC

Shire plc (LSE:SHP; NASDAQ:SHPG) said FDA approved Xiidra lifitegrast ( SHP606) to treat signs and symptoms of dry eye disease in adults. The company expects to launch Xiidra this quarter.

Shire obtained Xiidra via its 2013 acquisition of SARcode Bioscience Inc. It resubmitted an NDA for the candidate in January after FDA requested an additional clinical study and product quality information in a 2015 complete response letter. ...