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Medicines360 and Actavis Announce FDA Acceptance for Filing of NDA for Levosert™ IUD

Medicines360, a non-profit women’s health pharmaceutical company, and Actavis plc (NYSE: ACT), a leading global specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing Medicines360’s New Drug Application (NDA) for Levosert™ (levonorgestrel), a hormonal intrauterine contraceptive (IUC) for use by women to prevent pregnancy.

SAN FRANCISCO and DUBLIN – Medicines360, a non-profit women’s health pharmaceutical company, and Actavis plc (NYSE: ACT), a leading global specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing Medicines360’s New Drug Application (NDA) for Levosert™ (levonorgestrel), a hormonal intrauterine contraceptive (IUC) for use by women to prevent pregnancy.

In June 2013, Medicines360 and Actavis announced that they had entered into a partnership that will make Levosert™ available in the U.S. commercially and at an affordable price in U.S. public sector clinics.  As part of this agreement, Actavis licensed the U.S. commercial rights for Levosert™, and Medicines360 retained rights to market the product in the U.S. public sector, including family planning clinics that provide services to low-income women.

The acceptance for filing means the FDA has determined that the application is sufficiently complete to permit a substantive review.  The acceptance for filing does not provide any assurance that the FDA will ultimately approve the NDA.  Under the Prescription Drug User Fee Act (PDUFA), the FDA’s goal under standard review is to review and act on the NDA by February 28, 2015.

 

About Medicines360

Medicines360 is a non-profit women’s health pharmaceutical company and social enterprise. Through a unique operating model, Medicines360 reinvests profits generated through commercial sales revenue into advocacy, education, research and development with the goal of providing innovative, affordable, and sustainable medical solutions for women. Profits are a means to a mission, not a motive; Medicines360 exists to meet the contraceptive needs of all women.  For more information, visit .

 

About Actavis, Inc.

Actavis plc (NYSE:ACT), headquartered in Dublin, Ireland, is a unique specialty pharmaceutical company focused on developing, manufacturing and commercializing high quality affordable generic and innovative branded pharmaceutical products for patients around the world.

Actavis markets a broad portfolio of branded and generic pharmaceuticals and develops innovative medicines for patients suffering from diseases principally in the central nervous system, gastroenterology, women’s health, urology, cardiovascular, respiratory and anti-infective therapeutic categories.  The Company is an industry leader in product research and development, with one of the broadest brand development pipelines in the pharmaceutical industry, and a leading position in the submission of generic product applications.  Actavis has commercial operations in more than 60 countries and operates more than 30 manufacturing and distribution facilities around the world.

For press release and other company information, visit Actavis’ Web site at http://www.actavis.com.

 

Forward Looking Statement

Statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Actavis’ current perspective of existing trends and information as of the date of this release. Except as expressly required by law, Actavis disclaims any intent or obligation to update these forward-looking statements. Actual results may differ materially from Actavis’ current expectations depending upon a number of factors affecting Actavis’ business. These factors include, among others, the difficulty of predicting the timing or outcome of FDA approvals or actions, if any; the impact of competitive products and pricing; market acceptance of and continued demand for Actavis’ products, ; difficulties or delays in manufacturing; and other risks and uncertainties detailed in Actavis’ periodic public filings with the Securities and Exchange Commission, including but not limited to Actavis plc’s Annual Report on form 10-K for the year ended December 31, 2013, Quarterly Report on form 10-Q for the quarter ended March 31, 2014 and Current Report on form 8-K filed on May 20, 2014 and from time to time in Actavis’ other investor communications.  Except as expressly required by law, Actavis disclaims any intent or obligation to update these forward-looking statements.

 

ACTAVIS CONTACTS:         

Investors:

Lisa DeFrancesco

(862) 261-7152

 

Media:

Charlie Mayr

(862) 261-8030

David Belian

(862) 261-8141

 

MEDICINES360 CONTACTS:        

Pamela Weir

(415) 403-8987

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About Medicines360

Located in San Francisco, California, Medicines360 is a global nonprofit pharmaceutical organization with a mission to accelerate the timeline from health innovation to access for all women. Medicines360 is committed to working with healthcare providers, advocacy groups, and patients to deliver innovative and meaningful treatments that help women around the world have greater access to the medicines they need. For more information, visit www.medicines360.org.

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©2022 Medicines360. A 501(c)(3) tax-exempt organization. Medicines360® and its design are registered trademarks of Medicines360. 

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.

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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.