The FDA approved the first generics of the direct oral anticoagulant rivaroxaban, the agency announced on Tuesday.

Two companies have received approved for a generic of the 2.5 mg tablet of anticoagulant rivaroxaban, which is used to reduce ...

administered in a blinded fashion or oral rivaroxaban (20 mg once daily) administered in an open-label fashion in a 1:1:1 ratio. The primary end point was major or clinically relevant nonmajor ...

The approval is only for the 2.5mg tablet. Xarelto is also available in 10mg, 15mg, and 20mg tablets, as well as an oral suspension (1mg/mL), to treat various conditions.

The mean follow-up duration was 20 months. In the NOAC group, apixaban (Eliquis; Bristol Myers Squibb/Pfizer) was used in four trials, rivaroxaban (Xarelto; Janssen/Bayer) in two trials, dabigatran ...

Events Rivaroxaban (number per 100 patient years ... 5 1.03 (0.96–1.11); p = 0.44 Major bleeding 3.6 3.4 1.04 (0.90–1.20); p = 0.58 Decrease in hemoglobin ≥2 g/dl 2.8 2.3 1.22 (1.03 ...

A systematic review and meta-analysis of nine trials comparing non-vitamin K oral anticoagulants with low-dose aspirin revealed a link between rivaroxaban and higher rates of major bleeding and ...

Rivaroxaban (Xarelto) was also associated with higher risk than apixaban (42.94 vs 20.05 per 1,000 person-years, HR 2.15, 95% CI 1.18-3.94), again with a stronger association in those using ART ...

The Food and Drug Administration (FDA) has approved the first generics of Xarelto ® (rivaroxaban) 2.5mg. Xarelto 2.5mg is used, in combination with aspirin, to: Reduce the risk of major cardiovascular ...