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FDA Approves First Generics of Xarelto
FDA has approved the first generics of Xarelto (rivaroxaban) tablets to reduce the risk of major cardiovascular events in adult patients with coronary artery disease (CAD) and to reduce the risk of major thrombotic vascular events in adult patients with peripheral artery disease (PAD), including patients who have recently undergone a lower extremity revascularization procedure due to symptomatic PAD.
Anticoagulants like rivaroxaban are among the most commonly prescribed medications in the U.S., and the approval of the first generics of rivaroxaban will provide more treatment options for American patients who rely on anticoagulant medications.
Addressing the challenges related to developing generics and promoting more generic competition is a key part of FDA’s Drug Competition Action Plan and the agency’s efforts to help increase patient access to more affordable medicines. First generics are considered a public health priority, and FDA prioritizes reviews of applications for these products, which open the market to generic competition.
For at-risk patients, such as those with coronary artery disease or peripheral artery disease, the risk of major cardiovascular events or major thrombotic vascular events such as heart attack or stroke related to blood clots forming in the body and traveling to the brain is a serious concern.
Rivaroxaban will be dispensed with a Medication Guide for patients that provides instructions on its use and drug safety information. Rivaroxaban contains a boxed warning alerting health care providers that there is an increased risk of thrombotic events, which occur when blood clots form inside a blood vessel, or strokes if a patient stops using rivaroxaban too early. Additionally, epidural or spinal hematomas (bleeding outside of blood vessels) may occur in patients treated with rivaroxaban who are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Health care professionals should consider these risks when scheduling patients for spinal procedures and counsel patients on signs and symptoms of possible bleeding.
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