J&J’s Janssen division received a complete response from the FDA to its sNDA for Xarelto (rivaroxaban) for risk reduction in patients with acute coronary syndrome. The agency was evaluating Xarelto as a clot-prevention measure individuals with acute coronary artery disease, which an increase the risk of heart attack.
The FDA based its decision on the recommendation of its advisory committee, which noted that some information was missing from the company’s supplemental new drug application.
“We will continue to work with the FDA to fully address their questions as quickly as possible,’’ said Paul Burton, vice president, J&J’s Janssen division.
Ref: Janssen press release