22 July 2014 - Pharmaceutical company Medicines360 disclosed on Monday that the US Food and Drug Administration (FDA) has accepted for filing its New Drug Application (NDA) for Levosert in partnershp with Actavis (NYSE:ACT).

The companies added that Levosert (levonorgestrel) is a hormonal intrauterine contraceptive (IUC) for use by women to prevent pregnancy.

In June 2013, Medicines360 and Actavis had signed a partnership to launch Levosert at an affordable price in the US public sector clinics. Actavis licensed the US commercial rights for Levosert, and Medicines360 retained rights to market the product in the US public sector, including family planning clinics.

Under the Prescription Drug User Fee Act (PDUFA), the FDA's goal under standard review is to review and act on the NDA by 28 February 2015.