ARTICLE | Clinical News

Crinone regulatory update

July 4, 2011 7:00 AM UTC

FDA accepted for review an NDA from Columbia for Prochieve vaginal progesterone gel to reduce the risk of preterm birth in women with short urterine cervical length in the mid-trimester of pregnancy. The PDUFA date is Feb. 26, 2012. Columbia withdrew a previous request for Priority Review after meeting with FDA and determining that a standard review would give the agency the "appropriate time frame to complete its review of the application, including empaneling an agency advisory committee, if necessary." ...