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Bayer HealthCare Has Failed to Win The Backing of The US FDA's Cardiovascular

Jan 20, 2014

Bayer HealthCare has failed to win the backing of the US FDA's Cardiovascular and Renal Drugs Advisory Committee to expand the use of its oral anticoagulant Xarelto (rivaroxaban) 2.5 mg twice daily (BID) in combination with standard ...

Tags: FDA Panel, ACS Patients

Janssen Research & Development Has Submitted Supplemental New Drug Applications

Dec 5, 2012

Janssen Research & Development has submitted supplemental New Drug Applications (sNDAs) to the US Food and Drug Administration (FDA) for the use of Xarelto (rivaroxaban), an oral anticoagulant. Janssen said the drug is used to treat ...

Tags: Xarelto, rivaroxaban, DVT, pulmonary embolism, VTE

Janssen Research & Development Has Submitted a Supplemental New Drug Application

Dec 3, 2012

Janssen Research & Development has submitted a supplemental new drug application (sNDA) with FDA, seeking approval to use Xarelto (rivaroxaban), an oral anticoagulant, to reduce the risk of stent thrombosis in patients with acute coronary ...

Tags: Xarelto, new drug application, pharmaceutical product

Bayer Oral Anticoagulant Xarelto Has Gained Positive CDR Recommendation

Nov 28, 2012

Bayer oral anticoagulant Xarelto has gained positive common drug review (CDR) recommendation from the Canadian Agency for Drugs and Technologies in Health for the prevention of stroke and systemic embolism in atrial fibrillation (AF) ...

Tags: Bayer oral anticoagulant Xarelto, CDR Recommendation, Stroke Prevention

rivaroxaban

Bayer HealthCare Has Failed to Win The Backing of The US FDA's Cardiovascular

Janssen Research & Development Has Submitted Supplemental New Drug Applications

Janssen Research & Development Has Submitted a Supplemental New Drug Application

Bayer Oral Anticoagulant Xarelto Has Gained Positive CDR Recommendation

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