FDA Roundup: February 28, 2025

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 approved Odactra to include use in individuals 5 through 11 years of age to treat house dust mite induced nasal inflammation (allergic rhinitis), with or without eye inflammation (conjunctivitis). Odactra is an allergen extract immunotherapy that is administered under the tongue (sublingual) and had been approved for use in individuals 12 through 65 years of age. The prescribing information includes a boxed warning to inform that Odactra can cause severe allergic reactions that may be life-threatening. As with other FDA-approved allergen extracts administered sublingually, patients receiving Odactra should be prescribed epinephrine.
• On Monday, the FDA updated the outbreak advisory: Outbreak Investigation of Listeria monocytogenes: Frozen Supplemental Shakes (February 2025) to include that Lyons Magnus LLC recalled 4 oz. Lyons ReadyCare and Sysco Imperial Frozen Supplemental Shakes. As of February 24, 2025, a total of 38 people infected with the outbreak strain of Listeria monocytogenes have been reported from 21 states. Of the 38 people for whom information is available, 37 people have been hospitalized, and 12 deaths have been reported.
• On Monday, the FDA cleared Tandem Diabetes Care, Inc.’s Control-IQ+ technology, an interoperable automated glycemic controller (iAGC) that is a software-only, prescription use, device. The device is intended for use with compatible integrated continuous glucose monitors (iCGM) and alternate controller enabled (ACE) pumps to automatically increase, decrease, and suspend delivery of basal insulin based on iCGM readings and predicted glucose values. It can also deliver certain insulin doses (correction boluses) necessary when the glucose value is predicted to exceed a predefined target, which is typically calculated based on carbohydrate intake, exercise, and sleep schedule.  This clearance allows the device to be used for the management of type 1 diabetes in individuals two years and older and for the management of type 2 diabetes in individuals 18 years and older, where the prior version was only for type 1 diabetes. This is the latest example of the FDA’s ongoing commitment to help advance the development of products that can improve the management of diabetes.
• On Friday, February 21, the FDA approved for marketing a software update to Medtronic Inc.’s Activa, Percept and SenSight Deep Brain Stimulation Therapy System, an implantable device that delivers low-intensity electrical pulses to nerve centers in the brain as part of deep brain stimulator (DBS) therapy for Parkinson’s Disease (PD). This first-of-its-kind software update will provide the user with an option for adaptive deep brain stimulation (aDBS), which individualizes the DBS therapy by adjusting the stimulation level based on detected brain signals surrounding the DBS electrode of the implant. The new programming option is intended to reduce some of the symptoms in patients diagnosed with levodopa-responsive PD, specifically those with symptoms not been adequately controlled with medicine for at least four years.

Related Information

###