"FDA again seeks more info on rivaroxaban in ACS"
Heart Mar 1
http://www.theheart.org/article/1513837.do
"Xarelto, Bayer Healthcare/Janssen Pharmaceuticals) will not be getting the much-hoped-for approval in patients with ACS this week [1]. The FDA has issued a complete response letter (CRL) to Janssen regarding the company's supplemental new drug application for rivaroxaban in patients with ACS."