Drug news
FDA issues Complete Response Letter relating to Xarelto (Bayer/Janssen Pharma) for Acute Coronary Syndrome
Bayer HealthCare announced that the FDA has issued a Complete Response Letter regarding the supplemental New Drug Application (sNDA) for the oral anticoagulant Xarelto (rivaroxaban) 2.5 mg BID in combination with standard antiplatelet therapy for the reduction of secondary cardiovascular events (cardiovascular death, myocardial infarction or stroke) in patients with Acute Coronary Syndrome (ACS). Bayer is evaluating the Complete Response Letter from the FDA together with its cooperation partner Janssen Research & Development, LLC, and will respond to the Agency�s questions.
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