FDA Roundup: August 16, 2024

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Aug 16, 2024, 14:51 ET

SILVER SPRING, Md., Aug. 16, 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 issued notice of a Warning Letter sent to AUSTROFOOD S.A.S. (Austrofood), the manufacturer of the apple cinnamon fruit puree pouches that were recalled last year and that were found to contain elevated levels of lead and chromium. The letter is part of the agency's ongoing efforts to enhance the safety of cinnamon, ground spices, and other foods, particularly those consumed by babies and young children.
On Thursday, the FDA approved Imfinzi (durvalumab, AstraZeneca) with platinum-containing chemotherapy as neoadjuvant treatment, followed by single-agent durvalumab as adjuvant treatment after surgery for adults with resectable (tumors ≥ 4 cm and/or node positive) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements. Full prescribing information for Imfinzi will be posted on Drugs@FDA.
On Wednesday, the FDA updated the advisory for the investigation of Salmonella infections linked to cucumbers. Laboratory, epidemiological, and traceback data have determined that cucumbers from Bedner Growers, Inc., of Boynton Beach, Florida, and Thomas Produce Company, of Boca Raton, Florida, are likely sources of illnesses in this outbreak; however, these growers do not account for all the illnesses in this outbreak. Salmonella Braenderup was detected in samples of canal water used by Thomas Produce Company. Whole Genome Sequencing analysis determined that the water used by Thomas Produce Company contained the Salmonella that is a match to a strain of Salmonella Braenderup that is causing some of the illnesses in this outbreak. Thomas Produce Company's cucumber growing and harvesting season is over. There is no product from these farms on the market and likely no ongoing risk to the public.
On Wednesday, the FDA advised consumers in Skip the Antibacterial Soap; Use Plain Soap and Water that there isn't evidence to show that over-the-counter (OTC) antibacterial soaps are better at preventing illness than washing with plain soap and water. In fact, some data suggest that antibacterial ingredients could do more harm than good over the long-term.
On Wednesday, the FDA approved Niktimvo (axatilimab-csfr, Incyte Corporation), a colony stimulating factor-1 receptor-blocking antibody, for the treatment of chronic graft-versus-host disease (cGVHD) after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg. Full prescribing information for Niktimvo will be posted on Drugs@FDA.
On Tuesday, the FDA released the results of the second retail sampling survey that tested dairy products for the highly pathogenic avian influenza A (H5N1). No viable virus was detected in the samples collected from retail locations and analyzed between June 18-July 31, 2024. These results strengthen previous assessments that commercial pasteurization inactivates the H5N1 virus. More information and results from first and second retail sampling surveys can be found at Updates on Highly Pathogenic Avian Influenza (HPAI) H5N1 | FDA.
On Tuesday, the FDA updated the advisory, Investigation of Illnesses: Diamond Shruumz-Brand Chocolate Bars, Cones, & Gummies (June 2024), to include updated case counts. Additionally, the list of store names and locations where the recalled products were available for retail sale has been updated.
On Monday, the FDA granted a marketing authorization to SoClean Inc. for the SoClean 3+ bacterial reduction device for use with continuous positive airway pressure (CPAP) accessories [two hoses (ResMed ClimateLine Air tubing, and SlimLine tubing) and one mask (ResMed Mirage FX mask)] for the ResMed AirSense 10 CPAP device. The SoClean 3+ device is used in CPAP therapy for sleep apnea. It does not replace the cleaning steps recommended by CPAP device manufacturers. To date, there are no FDA cleared or approved devices for cleaning, disinfecting, or sanitizing CPAP machines.

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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