The U.S. Food and Drug Administration approved Adlyxin (lixisenatide), a once-daily injection to improve glycemic control (blood sugar levels), along with diet and exercise, in adults with type 2 diabetes.
Category Archives: Drug Safety Information Podcasts
FDA updates warnings for fluoroquinolone antibiotics
The U.S. Food and Drug Administration today approved safety labeling changes for a class of antibiotics, called fluoroquinolones, to enhance warnings about their association with disabling and potentially permanent side effects and to limit their use in patients with less serious bacterial infections.
Federal court orders Minnesota sprout and noodle company to cease operations due to unsanitary conditions
On July 15, 2016, the U.S. District Court for the District of Minnesota entered a consent decree of permanent injunction between the United States and Kwong Tung Foods, Inc., doing business as Canton Foods; its president and owner, Vieta “Victor” C. Wang; and its vice-president, Juney H. Wang, for significant and ongoing violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and its implementing regulations. The business, located in Minneapolis, Minnesota, sells rice and wheat noodles, and mung bean and soy bean sprouts.
FDA approves first intraocular lens with extended range of vision for cataract patients
The U.S. Food and Drug Administration today approved the first intraocular lens (IOL) that provides cataract patients with an extended depth-of-focus, which helps improve their sharpness of vision (visual acuity) at near, intermediate and far distances.
FDA approves new medication for dry eye disease
The U.S. Food and Drug Administration approved Xiidra (lifitegrast ophthalmic solution) for the treatment of signs and symptoms of dry eye disease, on Monday, July 11, 2016. Xiidra is the first medication in a new class of drugs, called lymphocyte function-associated antigen 1 (LFA-1) agonist, approved by the FDA for dry eye disease.
FDA approves first MRI-guided focused ultrasound device to treat essential tremor
The U.S. Food and Drug Administration today approved the first focused ultrasound device to treat essential tremor in patients who have not responded to medication. ExAblate Neuro uses magnetic resonance (MR) images taken during the procedure to deliver focused ultrasound to destroy brain tissue in a tiny area thought to be responsible for causing tremors.
FDA approves Differin Gel 0.1% for over-the-counter use to treat acne
The U.S. Food and Drug Administration today approved Differin Gel 0.1% (adapalene), a once-daily topical gel for the over-the-counter (OTC) treatment of acne. Differin Gel 0.1% is approved for use in people 12 years of age and older.
FDA approves first HPV test for use with SurePath Preservative Fluid
The U.S. Food and Drug Administration today approved the Roche cobas HPV Test as the first test for Human Papilloma Virus (HPV) that can be used with cervical cells obtained for a Pap test and collected in SurePath Preservative Fluid.
FDA advances Precision Medicine Initiative by issuing draft guidances on next generation sequencing-based tests
FDA advances Precision Medicine Initiative by issuing draft guidances on next generation sequencing-based tests
Federal court orders Alabama seafood company to cease production due to food safety violations
On Tuesday, July 5, 2016, the U.S. District Court for the Southern District of Alabama entered a consent decree of permanent injunction between the United States and BEK Catering LLC. The business, owned by Billy B. Stembridge, Jr. and Kyle D. Huxen, operates as Floppers Foods selling ready-to-eat seafood products and is based in Daphne, Alabama.