Product Details
NorLevo® is an oral emergency contraceptive, which is taken within 72 hours after unprotected sexual intercourse or contraceptive failure to prevent unwanted pregnancy. Its active ingredient, levonorgestrel, is listed as an essential drug by WHO.
NorLevo® was originally developed by Laboratoires HRA Pharma. It was first approved in Europe (France) in 1999 and has since been approved in some 50 countries worldwide.
In April 2001, Sosei acquired the exclusive distribution rights for Japan and Australia form HRA Pharma. In Japan, NorLevo® was developed by Sosei Group's wholly owned subsidiary Sosei Co. Ltd.
Data from Phase III trial that was designed to evaluate the safety and prevented pregnancy rate of NorLevo® in Japanese adult female subjects, showed that in 62 out of 63 subjects pregnancy was successfully prevented and no serious adverse events were reported. Based on this, Sosei filed NDA application in September 2009 and was granted the approval by the Japan Ministry of Health, Labour and Welfare in February 2011.
According to the distribution agreement, which Sosei signed with ASKA Pharmaceutical Co., Ltd. in November 2009, ASKA will be responsible for commercialization of NorLevo® in Japan. NorLevo® was launched on 24 May 2011.
Also, Sosei licenced marketing rights for NorLevo® in Australia to Sandoz Pty Ltd. in December 2005.
