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Top 10 FDA news stories posted in 2018
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Endocrine Today has compiled a list of the top 10 FDA approvals and news reports posted in 2018. This year, Healio.com/Endocrinology readers were interested in the Freestyle Libre, rare genital infection associated with SGLT2 inhibitors, BPA in consumer products, testosterone self-injection for hypogonadism and more.
FDA approves 14-day FreeStyle Libre CGM sensor for diabetes
In July, the FDA approved the FreeStyle Libre flash glucose monitoring system, which allows patients with diabetes to wear the sensor up to 14 days with high accuracy, Abbott announced in a press release.
FDA approves mobile app for Freestyle Libre
The FDA approved a mobile app for use with the Freestyle Libre 10-day and 14-day glucose monitoring systems, allowing patients with diabetes to monitor glucose readings on their compatible iPhone devices, Abbott announced in a press release.
FDA, endocrinologists at odds over agency’s latest BPA safety claims
The HHS National Toxicology Program issued a draft report in February suggesting that rodents exposed to the endocrine-disrupting chemical bisphenol A experienced only “minimal effects,” leading the FDA to reaffirm its stance that the chemical is “safe for consumers” at current levels in food packaging.
FDA approves CV events indication for Invokana
The FDA has approved an expanded indication for the SGLT2 inhibitor canagliflozin to include language in the prescribing information that the drug can reduce risk for major adverse cardiovascular events, including myocardial infarction, stroke or CV death, in adults with type 2 diabetes and established CVD, according to a press release from Janssen Pharmaceuticals.
FDA warns of rare genital infection associated with SGLT2 inhibitors for diabetes
The FDA issued a drug safety communication for health care providers and the public in August following reports of necrotizing fasciitis of the perineum, also known as Fournier’s gangrene, in people prescribed drugs in the SGLT2 inhibitor class of diabetes medications.
FDA approves testosterone self-injection for hypogonadism in men
The FDA approved Antares Pharma’s testosterone enanthate injection Xyosted for testosterone replacement therapy in men with primary hypogonadism or hypogonadotropic hypogonadism, the company announced in a press release.
Beta Bionics receives FDA approval to begin bionic pancreas study recruitment
The FDA granted an investigational device exemption to Beta Bionics that will allow the company to begin recruitment for the first home-based studies testing the insulin-only configuration of its bionic pancreas system, according to an industry press release.
FDA approves bioidentical hormone therapy for menopausal hot flashes
The FDA approved the first bioidentical hormone therapy combination of estradiol and progesterone for moderate to severe vasomotor symptoms associated with menopause, TherapeuticsMD announced in a press release.
FDA clears first glucose meter for critically ill patients
The FDA granted 510(k) clearance for the first finger-stick capillary testing meter for critically ill patients with and without diabetes, Nova Biomedical announced in a press release.
FDA committee narrowly supports continued CV outcomes trials for diabetes drugs
An FDA advisory committee voted 10-9 in favor of supporting continued agency-recommended cardiovascular outcomes trials to demonstrate safety for all type 2 diabetes drugs, with most committee members recommending modifications to the 2008 guidance after a decade of data and no indication of increased CV risk.