The United States Food and Drug Administration (USFDA) 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). Xarelto is marketed by Janssen Pharmaceuticals, Inc.
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. Lupin is introducing rivaroxaban tablets, 2.5 mg to the market.
The drug is also indicated 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 United States, and the approval of the first generics of rivaroxaban will provide more treatment options for American patients who rely on anticoagulant medications, the federal body said in a statement.
“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,” FDA stated.
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.
FDA also stated 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, it added.
“Health care professionals should consider these risks when scheduling patients for spinal procedures and counsel patients on signs and symptoms of possible bleeding,” it stated.