June 14, 2024 - FDA Roundup: June 14, 2024

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: 

• Today, the FDA issued a proposed exemption for certain cottage cheese products from the requirements of the Food Traceability Rule. The proposal would exempt Grade “A” cottage cheese that appears on the Interstate Milk Shippers List from the requirements of the rule.
• Today, the FDA announced a recall initiated by Merit Medical Systems, Inc. in direct response to the Jiangsu Shenli Medical Production Co Ltd. recall to stop using its unauthorized plastic syringes. Merit includes the affected Jiangsu Shenli syringes in multiple kits. A timeline and summary of activities related to this issue, including recalls, is provided in FDA Actions. The FDA recommendations have not changed. We will continue our efforts to evaluate problems with syringes made in China and keep the public informed as new or additional information becomes available.
• On Thursday, the FDA announced the issuance of warning letters to six online retailers for selling unauthorized e-liquid products from the Bad Drip brand that imitate prescription drug bottles. The retailers were also warned for selling unauthorized flavored, disposable e-cigarettes, including those under the brand names Funky Republic and HQD. 
• On Thursday, the FDA granted accelerated approval to repotrectinib (AUGTYRO, Bristol-Myers Squibb Company) for adult and pediatric patients 12 years and older with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity, and that have progressed following treatment or have no satisfactory alternative therapy. The most common (>20%) adverse reactions were dizziness, dysgeusia, peripheral neuropathy, constipation, dyspnea, fatigue, ataxia, cognitive impairment, muscular weakness, and nausea. Full prescribing information for Augtyro will be posted on Drugs@FDA.
• On Thursday, the FDA posted a CDER Conversation with Robert Ball, M.D., M.P.H., ScM, Deputy Director of CDER’s Office of Surveillance and Epidemiology. Dr. Ball explains the Emerging Drug Safety Technology Meeting program and the application of artificial intelligence (AI) in pharmacovigilance (PV) based on his experience of more than a decade researching and developing AI systems in PV. For more information, read the CDER Conversation: Emerging Drug Safety Technology Meeting Program.
• On Thursday, the FDA updated its advice to manufacturers of COVID-19 vaccines (2024-2025 Formula). The FDA initially advised the manufacturers of the licensed and authorized COVID-19 vaccines that the COVID-19 vaccines (2024-2025 Formula) for use in the United States beginning in fall 2024 should be monovalent JN.1 vaccines.  Based on the most current available data, along with the recent rise in cases of COVID-19 in areas of the country, the agency has further determined that the preferred JN.1-lineage for the COVID-19 vaccines (2024-2025 Formula) is the KP.2 strain, if feasible. This change is intended to ensure that the COVID-19 vaccines (2024-2025 Formula) more closely match circulating SARS-CoV-2 strains. The FDA has communicated this change to the manufacturers of the licensed and authorized COVID-19 vaccines. The agency does not anticipate that a change to KP.2 will delay the availability of the vaccines for the United States.
• On Thursday, the FDA announced the Transparency for Machine Learning-Enabled Medical Devices: Guiding Principles, published jointly by the FDA, Health Canada, and the United Kingdom’s Medicines and Healthcare products Regulatory Agency. For a machine learning-enabled medical device, effective transparency helps ensure that information that could impact patient risks and outcomes is communicated to all the people who could be interacting with the medical device, including health care providers, payors, and others, to help make informed decisions. Transparency across health care is an international priority and the FDA will continue to collaborate with international partners in this area.
• On Wednesday, the FDA granted traditional approval to selpercatinib (Retevmo) for adult and pediatric patients 2 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). Selpercatinib received accelerated approval for this indication for patients 12 years of age and older in 2020. The most common adverse reactions (≥25%) were edema, diarrhea, fatigue, dry mouth, hypertension, abdominal pain, constipation, rash, nausea, and headache.  Full prescribing information for Retevmo will be posted on Drugs@FDA.
• On Tuesday , the United States District Court for the District of Colorado entered a consent decree of permanent injunction against Boosted LLC (who also does business as Boosted E-Juice, Boosted, and Live Boosted) and Cory Vigil, owner of Boosted LLC. The consent decree prohibits Boosted LLC and Mr. Vigil from manufacturing, selling, or distributing any new tobacco products until they meet certain requirements. According to the complaint filed by the U.S. Department of Justice on FDA’s behalf, defendants were previously warned they were in violation of the Federal Food, Drug, and Cosmetic Act’s premarket review requirements for manufacturing, selling, and distributing new tobacco products by failing to first obtain marketing authorization from FDA.
• On Tuesday, the FDA posted warning letters to four companies marketing the unapproved animal drug toltrazuril to treat conditions like coccidiosis and equine protozoal myeloencephalitis (EPM). The companies included All Things Bunnies Inc., Linessa Farms LLC, TotalTotrazuril.com and Toltrazuril Shop. 
• On Tuesday, the FDA approved phenylpropanolamine hydrochloride chewable tablets for the control of urinary incontinence due to a weakening of the muscles that control urination (urethral sphincter hypotonus) in dogs. This is the first generic phenylpropanolamine hydrochloride chewable tablets for dogs. Phenylpropanolamine Hydrochloride chewable tablets contain the same active ingredient (phenylpropanolamine hydrochloride) in the same concentration and dosage form as the approved brand name drug product, Proin chewable tablets, which were first approved on Aug. 4, 2011.

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