Medicines360 and Actavis Announce FDA Acceptance for Filing of NDA for Levosert™ IUD
Published 21 July 2014, San Francisco, CA and Dublin, Ireland
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.
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.