SILVER SPRING, Md., March 4, 2025 — The U.S. Food and Drug Administration is providing a quick overview of recent news from across the agency.

• On Monday, the FDA granted approval for the first generic versions of Xarelto (rivaroxaban), 2.5 mg tablets. These generics are indicated to lower the risk of significant cardiovascular events in adults with coronary artery disease (CAD) and to decrease the risk of major thrombotic vascular events in adults suffering from peripheral artery disease (PAD), including those who have recently undergone a lower extremity revascularization procedure for symptomatic PAD. Given that anticoagulants (blood thinners) are among the most frequently prescribed medications in the U.S., the approval of these rivaroxaban generics is expected to have a substantial impact on American patients who depend on these medications. The FDA remains committed to approving safe and effective generics to broaden treatment options for patients.
   
• On Friday, the FDA announced updated labeling requirements for testosterone products. These revisions are based on findings from the TRAVERSE (Testosterone Replacement Therapy for Assessment of Long-term Vascular Events and Efficacy Response in Hypogonadal Men) clinical trial, as well as data from mandatory postmarket ambulatory blood pressure monitoring (ABPM) studies. The revised labels will include a new warning addressing the potential for increased blood pressure with testosterone products that do not currently carry such a warning.
   
• On Friday, the FDA approved TNKase (tenecteplase) for the treatment of acute ischemic stroke (AIS) in adult patients. The most commonly reported side effect is bleeding. TNKase is administered intravenously, and recommended dosage information can be found in the prescribing information.

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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products.

 

SOURCE U.S. Food and Drug Administration