Washington, DC - The U.S. Food and Drug Administration approved the first generic version of EpiPen and EpiPen Jr (epinephrine) auto-injector for the emergency treatment of allergic reactions, including those that are life-threatening (anaphylaxis), in adults and pediatric patients who weigh more than 33 pounds. Teva Pharmaceuticals USA gained approval to market its generic epinephrine auto-injector in 0.3 mg and 0.15 mg strengths.

Washington, DC - Over the last several years, there’s been growing scientific and public interest in the role of microorganisms in the maintenance of overall health and prevention and treatment of disease. Today, more so than ever before, consumers are familiar with the phrase “good” or “helpful” bacteria and the expectation that it will aid in treating or preventing various illnesses. As the field advances, the U.S. Food and Drug Administration is playing a key role in sorting through the science and the science fiction of this evolving field.

Dallas, Texas - A new test to assess a whether or not someone is having a heart attack upon arriving in the emergency room was safe and effective, ruling out heart attack in emergency room patients faster than a conventional method, according to new research in the American Heart Association’s journal Circulation. 

Washington, DC - Researchers have found that a group of viruses that cause severe stomach illness - including the one famous for widespread outbreaks on cruise ships - get transmitted to humans through membrane-cloaked “virus clusters” that exacerbate the spread and severity of disease. Previously, it was believed that these viruses only spread through individual virus particles. The discovery of these clusters, the scientists say, marks a turning point in the understanding of how these viruses spread and why they are so infectious. This preliminary work could lead to the development of more effective antiviral agents than existing treatments that mainly target individual particles. 

Washington, DC - The U.S. Food and Drug Administration Friday approved Annovera (segesterone acetate and ethinyl estradiol vaginal system), which is a combined hormonal contraceptive for women of reproductive age used to prevent pregnancy and is the first vaginal ring contraceptive that can be used for an entire year. Annovera is a reusable donut-shaped (ring), non-biodegradable, flexible vaginal system that is placed in the vagina for three weeks followed by one week out of the vagina, at which time women may experience a period (a withdrawal bleed). This schedule is repeated every four weeks for one year (thirteen 28-day menstrual cycles).

Washington, DC - An intervention designed to help first-time mothers effectively respond to their infant’s cues for hunger, sleep, feeding, and other infant behaviors significantly improved the body mass index (BMI) z-scores of the child through age 3 years compared with the control group. Results of the study, call Intervention Nurses Start Infants Growing on Health Trajectories (INSIGHT), published August 7 online in JAMA.