FDA accepts Allergan ’ s new drug application for Liletta contraception device

Allergan (NYSE:AGN) and the global nonprofit women’s health company Medicines360 said today that the FDA accepted its supplemental New Drug Application for the Liletta contraception device. The companies are asking the federal watchdog to extend the system’s duration of use from 3 years to 4 years. Liletta is a levonorgestrel-releasing intrauterine system that is placed in a woman’s uterus to prevent pregnancy for up to 3 years and is 99% effective, according to Dublin-based Allergan. The device is not permanent – a health care provider can take it out at any time, enabling the patient to choose between long-term or short-term contraception. Get the full story at our sister site, Drug Delivery Business News. The post FDA accepts Allergan’s new drug application for Liletta contraception device appeared first on MassDevice.
Source: Mass Device - Category: Medical Equipment Authors: Tags: Drug-Device Combinations Food & Drug Administration (FDA) Gynecological Pharmaceuticals Regulatory/Clearance Women's Health Allergan Inc. Medicines360 Source Type: news