Allergan/Medicines360, FDA accepts sNDA for Liletta

Allergan and Medicines360, a nonprofit global women’s health organization, announced that FDA has accepted a sNDA (supplemental New Drug Application) for contraceptive device Liletta. The sNDA is aimed at extending the duration of use for the device from three to four years. Liletta is a levonorgestrel-releasing system placed in a woman’s uterus to prevent pregnancy for up to three years and is 99% effective. The new application includes efficacy and safety data from an ongoing Phase III trial, Allergan informed. The trial, conducted in the US, has enrolled 1,751 women.
(Source Drug Delivery)