Mar 4, 2025   SOURCE: PR NewsWire

FDA Roundup: March 4, 2025

SILVER SPRING, Md., March 4, 2025 /PRNewswire/ -- Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:

    --  On Monday, the FDA approved the first generics of Xarelto (rivaroxaban),
        2.5 mg, 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 (blood thinners) are among the most commonly prescribed
        medications in the U.S., and Monday's 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.

    --  On Friday, the FDA informed sponsors of testosterone products of new
        labeling changes resulting from the results of the Testosterone
        Replacement Therapy for Assessment of Long-term Vascular Events and
        Efficacy Response in Hypogonadal Men (TRAVERSE) clinical trial and the
        results from required postmarket ambulatory blood pressure monitoring
        (ABPM) studies. The labeling changes include a new warning about the
        risk of increased blood pressure for testosterone products that
        currently do not contain such labeling information.
    --  On Friday, the FDA approved TNKase (tenecteplase) to treat acute
        ischemic stroke (AIS) in adults. The most common adverse reaction is
        bleeding. TNKase is for intravenous administration only and recommended
        dosing is available in the prescribing information.

Additional Resources:

    --  FDA Newsroom

Media Contact: FDA Office of Media Affairs, 301-796-4540
Consumer Inquiries: 888-INFO-FDA

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.

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SOURCE U.S. Food and Drug Administration