FDA

FDA OKs first generics for low-dose rivaroxaban

March 10, 2025

FDA approved the first generics of Xarelto (rivaroxaban) 2.5 mg tablets to reduce the risk of major CV events in adults with coronary artery disease (CAD) and to reduce the risk of major thrombotic vascular events in adults with peripheral artery disease (PAD), including patients who’ve recently undergone a lower extremity revascularization procedure due to symptomatic PAD.

According to an FDA statement, “the approval of the first generics of rivaroxaban, 2.5 mg, tablets will make a direct impact on American patients who rely on anticoagulant medications. Approving safe and effective generics to help provide patients more treatment options continues to be a priority for the FDA.”

Source:

FDA Roundup: March 4, 2025. Food and Drug Administration. 2025. https://www.fda.gov/news-events/press-announcements/fda-roundup-march-4-2025