FDA Roundup: OTC Continuous Glucose Monitors, Dapagliflozin for Pediatric T2D
Check out important updates from the FDA for the week of June 10.
FDA Approves 2 New OTC Continuous Glucose Monitors
The FDA provided clearance to 2 over-the-counter (OTC) continuous glucose monitor (CGM) systems from Abbott. The
The Libre Rio is the first OTC CGM that has a measurement range of 40-400 mg/dL, which allows the device to detect extremely low or high glucose events. The CGM provides measurements via a biosensor that is placed on the back of the arm for up to 15 days, which is compatible with a reader or smartphone app.
The Lingo CGM, designed for general adult use, can track glucose levels, provide personalized insights, and give customized coaching to “help people retrain their metabolism and improve their overall well-being.” The system uses a biosensor that is worn on the upper arm for 14 days. Paired with a smartphone app, the device continuously streams glucose data to give users insights on food reactions, exercise and daily stressors.
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FDA Approves Dapagliflozin to Treat Pediatric Patients with Type 2 Diabetes
The
The approval was based on data from the T2NOW trial (
“The prevalence of type-2 diabetes continues to rise in children and adolescents, yet oral treatment options have remained limited for this population,” Ruud Dobber, executive vice president of the Biopharmaceuticals Business Unit at AstraZeneca, said in a release. “Today’s approval represents an important milestone for pediatric patients living with type-2 diabetes in the US, extending this medicine’s potential benefits to even more patients facing high unmet needs…”
FDA, DOJ Launch Multi-Agency Task Force to Address Illegal E-Cigarettes
The US Department of Justice and the FDA
By uniting all available criminal and civil tools in an “all government” approach, the task force hopes to address nicotine addiction among American youth. The team will uphold the Prevent All Cigarette Trafficking Act of 2009, the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking Prevention and Tobacco Control Act, and other authorities, to investigate and prosecute new criminal, civil, seizure, and forfeiture actions associated with e-cigarettes.
In recent years, e-cigarette and nicotine companies have ramped up marketing tactics to appeal to young people. Manufacturers, distributors, and retailers promote candy- and fruit-flavored vapes, bright and colorful designs,2 and packaging meant to be easily concealed from parents and teachers. Although e-cigarette use among young people is down from 5.3 million in 2019 to 2.1 million in 2023, vaping among the population still represents a significant public health issue.
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