Women's Health Update - September 2018

www.fda.gov/womens

September 2018

Message from the Director

This month, we are excited to host a two-day scientific conference, “Opioid and Nicotine Use, Dependence, and Recovery: Influences of Sex and Gender” on September 27 and 28, 2018 to discuss sex and gender influences on opioid and tobacco use, abuse, and recovery with researchers, clinicians, and policy experts. If you have not already registered, I encourage you to register to view the webcast and share the meeting details with your networks. This will be a scientific conference not to be missed. As we transition into the fall season, I invite you to connect with us by signing up for other FDA OWH topic specific email updates, supporting one of our campaigns, and following us on Twitter and Pinterest. In addition, use the information in this eUpdate to stay informed about the latest women’s health news from FDA. Marsha Henderson, Associate Commissioner for Women's Health

Statement by FDA Commissioner Scott Gottlieb, M.D., on the agency’s ongoing work to forcefully address the opioid crisis Over the past 17 months, we’ve set out to address the opioid crisis forcefully, using all the agency’s tools and authorities. These steps have been part of a comprehensive approach that the Secretary of Health and Human Services has outlined. Our efforts at the U.S. Food and Drug Administration are part of these broader efforts and cut across three broad areas. Read the FDA Statement. FDA approves first generic version of EpiPen 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. Read the FDA News Release. FDA approves new vaginal ring for one year of birth control The U.S. Food and Drug Administration 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). Read the FDA News Release. FDA allows marketing of first direct-to-consumer app for contraceptive use to prevent pregnancy The U.S. Food and Drug Administration permitted marketing of the first mobile medical application (app) that can be used as a method of contraception to prevent pregnancy. The app, called Natural Cycles, contains an algorithm that calculates the days of the month a woman is likely to be fertile based on daily body temperature readings and menstrual cycle information, a method of contraception called fertility awareness. Designed for mobile devices, it is intended for use in pre-menopausal women aged 18 and older. Read the FDA News Release. FDA HIV Update - dolutegrevir label updates regarding neural tube defects FDA approved revisions to the TIVICAY (dolutegravir), TRIUMEQ (abacavir, dolutegravir, and lamivudine) and JULUCA (dolutegravir, rilpivirine) labels to include information on the risk of neural tube defects. There is a pregnancy exposure registry that monitors pregnancy outcomes in individuals exposed to TIVICAY during pregnancy. Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263. Read the FDA Safety Announcement. FDA approves first drug for neurotrophic keratitis, a rare eye disease The U.S. Food and Drug Administration approved the first drug, Oxervate (cenegermin), for the treatment of neurotrophic keratitis, a rare disease affecting the cornea (the clear layer that covers the colored portion of the front of the eye). Read the FDA News Release. Statement from FDA Commissioner Scott Gottlieb, M.D., and Janet Woodcock, M.D., director of the Center for Drug Evaluation and Research on FDA’s ongoing investigation into valsartan impurities and recalls and an update on FDA’s current findings “Millions of Americans take medication daily to control their blood pressure. We recently found that some generic versions of one medication, valsartan, contain an impurity that doesn’t meet FDA’s safety standards. Valsartan is an angiotensin II receptor blocker (ARB) that treats high blood pressure and heart failure. As our investigation continues to identify the root cause of this impurity, we want to take the opportunity to describe to the public what we are doing to find the cause of the impurity, to prevent a recurrence of this episode and to protect patients who need this medication.” Read the FDA Statement.

CDC Vital Signs on Million Hearts 2022 Heart attacks and strokes can be catastrophic, life-changing events that are all too common. Heart disease and stroke are preventable, yet they remain leading causes of death, disability, and healthcare spending in the US. Alarmingly, many of these events happen to adults ages 35-64—over 800,000 in 2016. Get details on the important role YOU play in helping reduce this number. Read the article, “Million Hearts 2022: Small Steps Are Needed for Cardiovascular Disease Prevention.” Learn more about the Preventing 1 Million Heart Attacks and Stroke initiative. Visit FDA’s Heart Health for Women’s webpage. Healthy Aging Tips for Women September is Healthy Aging Month. Healthy aging involves good habits like eating healthy, avoiding common medication mistakes. Connect older women with FDA resources to support healthy lifestyle choices and safe medication practices. Read 5 Healthy Aging Tips for Women. Get resources for managing symptoms before, during, and after menopause. Visit FDA’s Women’s Health Topics webpage for helpful tips on health issues that matter to you. Hispanic Women’s Health Encourage Hispanic women to take time for their health. During National Hispanic Heritage Month (September 15 – October 15), join us in celebrating Hispanic women’s heritage and health by sharing FDA health and safety information with the women in your community. Visit FDA’s Hispanic Women’s Health webpage. Download free publications in Spanish. Watch the ¡Nunca Más Novela Health Series!

Participate in Upcoming FDA Meetings

Parenteral Drug Association/Food and Drug Administration Joint Conference - Putting Patients First: Ensuring Innovation, Quality, Compliance, and Supply in an Evolving Environment September 24 – 26, 2018 Renaissance Washington, DC Downtown Hotel, Washington, DC Scientific Conference: Opioid and Nicotine Use, Dependence, and Recovery: Influences of Sex and Gender September 27 – 28, 2018, 8:30 am to 4:00 pm FDA White Oak Campus, Silver Spring, MD FDA Public Workshop: Clinical Trials to Optimize Outcomes in Early Breast Cancer October 29, 2018, 8:30 am to 4:15 pm FDA White Oak Campus, Silver Spring, MD Visit an OWH exhibit booth or presentation at these upcoming conferences. National Indian Health Board 35th Annual National Tribal Health Conference September 17 – 20, 2018, Oklahoma City, OK The North American Menopause Society Annual Meeting October 3 – 6, 2018, San Diego, CA Hispanic Association of College and Universities Annual Conference October 6 – 8, 2018, Atlanta, GA National Practitioners in Women’s Health 21st Annual Premier Women’s Healthcare Conference October 10 – 13, 2018, San Antonio, TX