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 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.