Janssen Resubmits Xarelto sNDA, Answers Complete Response Letter

Following setbacks in recent months for Janssen’s blood-clot drug Xarelto, the company has responded to an FDA complete response letter (CRL) on one sNDA for the drug and has re-submitted a separate sNDA. The Johnson & Johnson (J&J) subsidiary has provided more information on Xarelto (rivaroxaban) for reducing the risk of secondary cardiovascular events in patients with acute coronary syndrome (ACS). In June, Janssen received a CRL on that indication after an advisory committee narrowly voted down the drug.
Washington Drug Letter