FDA Roundup: December 27, 2024

SILVER SPRING, Md., Dec. 27, 2024 /PRNewswire/ -- Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:

    --  On Thursday, the FDA announced recommended changes to labeling for
        transmucosal buprenorphine products indicated to treat opioid use
        disorder. The recommended changes intend to encourage the submission of
        supplemental new drug applications to modify the labeling statements for
        buprenorphine-containing transmucosal products for the treatment of
        opioid dependence (BTODs), including to clarify that neither 16
        milligrams (mg) per day nor 24 mg/day should be interpreted as maximum
        dosages for transmucosal buprenorphine products.






    --  On Monday, the FDA issued a final rule establishing requirements for a
        nonprescription drug product with an additional condition for
        nonprescription use (ACNU)."This action demonstrates the FDA's
        commitment to improving public health by helping to broaden the types of
        nonprescription drugs available to consumers," said Patrizia Cavazzoni,
        M.D., director of the FDA's Center for Drug Evaluation and Research
        (CDER). "The FDA recognizes the benefit of providing consumers with
        options for additional types of nonprescription drug products, such as
        some drugs that are currently available only by prescription and that
        treat certain chronic diseases or conditions."See the CDER Statement for
        more information.


    --  On Monday, the FDA shared findings from an independent review of
        publications that document studies on contaminants in tampons. The
        review is also known as an independent, systematic, literature review.
        Although limitations were identified in the literature review, as is
        common, the findings did not identify safety concerns associated with
        tampon use and contaminant exposure. The FDA continues to recommend
        FDA-cleared tampons as a safe option for use as a menstrual product. The
        FDA continues to evaluate the safety and effectiveness of tampons, and
        an FDA laboratory study of metals in tampon materials is underway.
        Findings from that study will be shared when they are complete and peer
        reviewed.


    --  On Friday, December 20, the FDA approved Alhemo (concizumab-mtci) for
        routine prophylaxis to prevent or reduce the frequency of bleeding
        episodes in adult and pediatric patients 12 years of age and older with
        hemophilia A with factor VIII inhibitors or hemophilia B with factor IX
        inhibitors. Recommended dosing is available in the prescribing
        information. The most common adverse reactions (reported in at least 5%
        of patients) to Alhemo were injection site reactions and hives
        (urticaria). Hypersensitivity reactions including redness of skin
        (erythema), rash, itching (pruritus), and abdominal pain have occurred
        in patients treated with Alhemo. Patients with a history of serious
        hypersensitivity to Alhemo, its components, or its inactive ingredients
        should not use Alhemo.


    --  On Friday, December 20, the FDA's Office of Inspections and
        Investigations (OII) published a news package featuring the work of its
        field-based investigators who provide in-person oversight to help keep
        America's foods safe. In its latest Viewpoint, "During the Holidays and
        Throughout the Year, Food Safety Is Our Focus", new Deputy Associate
        Commissioner for Food Products Michael (Mick) Dutcher, DVM, praises his
        teams' dedication, including their rapid response to recent foodborne
        outbreaks. In a new WeAreOII staff profile Senior Investigator Megan
        Rand explains what it's like to be a foods investigator, as well as what
        motivates her. In the feature, OII Investigators Help Keep Food and
        Water Safe--at 35,000 Feet, you can learn how investigator Alan Escalona
        furthers FDA's public health mission, while working from the tarmac and
        inside an airplane.
    --  On Friday, December 20, the FDA approved for marketing Sequana Medical
        NV's alfapump System, an implanted pump indicated for the removal of
        excess peritoneal fluid in certain adult patients experiencing fluid
        buildup in the abdominal cavity due to liver cirrhosis. The alfapump
        System previously received a Breakthrough Device designation. The
        alfapump System continuously drains the excess fluid found between the
        lining of the abdominal wall and the covering of the abdominal organs,
        also known as the peritoneal cavity, into the bladder where it can exit
        the body through normal urination. This marketing approval provides
        patients with a potential alternative to repeat doctor visits for an
        abdominal tap (paracentesis). The alfapump System is intended for single
        patient use only.

Additional Resources:

    --  FDA Newsroom

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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.

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SOURCE U.S. Food and Drug Administration