Home > Newsletters > FDAnews Drug Daily Bulletin > Janssen Resubmits Xarelto sNDA, Answers Complete Response Letter
FDAnews Drug Daily Bulletin
Sept. 24, 2012 | Vol. 9 No. 187
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.
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