January 2017 - Medicines360

FDA Accepts for Filing Supplemental New Drug Application (sNDA) for LILETTA® (levonorgestrel-releasing intrauterine system) 52 mg

Allergan plc, (NYSE: AGN) a leading global pharmaceutical company, and Medicines360, a nonprofit global women’s health pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the company’s supplemental New Drug Application (sNDA) to potentially extend the duration of use for the prevention of pregnancy from up to three years to up to four years for LILETTA® (levonorgestrel-releasing intrauterine system) 52 mg.

Avibela® is a registered trademark of Medicines360 in countries across Africa, South and Southeast Asia, Central America, and the Caribbean.

Impact RH360® is a registered trademark of Medicines360 in Madagascar, Rwanda, Uganda, South Africa, and Zambia.

All other trademarks are property of their respective owners.

Tina Raine-Bennett, MD, MPH, FACOG

Chief Executive Officer

Tina Raine-Bennett, MD, MPH, is CEO of Medicines360. Previously, she served as a senior research scientist at the Kaiser Permanente Northern California Division of Research and the research director of the Women’s Health Research Institute. She is a Board-Certified Obstetrician Gynecologist who received her medical training at the University of California, San Diego, and post-graduate residency training and MPH at the University of Washington in Seattle, where she also completed a Robert Wood Johnson Clinical Scholars Fellowship. She was also senior staff physician at Kaiser Permanente and has a special interest in family planning and adolescent reproductive health.

As the director of the Women’s Health Research Institute, Dr. Raine-Bennett focused on expanding research on women’s health within the Division and translating women’s health research into clinical practice and policy within the Ob/Gyn departments in Northern California. She also promoted the involvement of clinicians in research designed to improve the health outcomes and healthcare experiences of women at Kaiser Permanente and women in general.

Prior to Kaiser Permanente, Dr. Raine-Bennett was a professor in the Department of Obstetrics, Gynecology, and Reproductive Sciences at University of California, San Francisco (UCSF). She was based at San Francisco General Hospital where she was also the medical director of the New Generation Health Center, a UCSF affiliate site that provides community-based reproductive health services. Dr. Raine-Bennett’s research has focused on contraceptive methods and on elucidating factors that influence contraceptive choice and continuation, and she was principal investigator on NIH grants to assess hormonal contraceptive use predictors and develop interventions to improve contraceptive access.

Her past and current research on emergency contraception has focused on the safety of making emergency contraception more accessible and she conducted a pivotal clinical trial to make emergency contraception available to teens without a prescription. She served on the editorial board of Obstetrics and Gynecology and has over 100 peer-reviewed publications. She was the Treasurer of the Board of Directors for the Society of Family Planning and Society of Family Planning Research Fund. She has also served as an examiner for the American Board of Obstetrics and Gynecology, and on national committees for the American College of Obstetrics and Gynecology and the National Medical Board of Planned Parenthood Federation of America.

Month: January 2017

FDA Accepts for Filing Supplemental New Drug Application (sNDA) for LILETTA® (levonorgestrel-releasing intrauterine system) 52 mg

AVIBELA can be made available in the following 88 countries