ARTICLE | Company News

Complete response for Cinryze scale-up

October 23, 2010 12:31 AM UTC

FDA issued a complete response letter regarding the expansion of industrial scale manufacturing for Cinryze from ViroPharma Inc. (NASDAQ:VPHM). According to ViroPharma, FDA requested responses to quality observations during a pre-approval inspection, as well as additional information and supporting documentation about technical processes. ViroPharma intends to request a meeting with FDA to discuss the steps necessary for approval. ...