Berlex Laboratories applies to market Mirena in US:
This article was originally published in Clinica
Executive Summary
Schering AG's Berlex Laboratories unit has filed a new drug application with the US FDA for its levonorgestrel-containing intra-uterine device, Mirena. The contraceptive, which delivers a small dose of locally acting hormone directly to the uterus, is marketed by Schering in countries in the European Union, Asia and Latin America, and is used by around 1.4 million women. It can remain in the uterus for five years, but can be removed at any time, and full fertility is restored within one month of removal, the company said.