Sosei Files NDA For NorLevo In Japan

Sosei has announced the submission of the New Drug Application (NDA) for the emergency contraceptive pill SOH-075 (NorLevo) to Ministry of Health, Labour and Welfare (MHLW) by Sosei Co., its wholly owned Japanese subsidiary.

NorLevo is an oral emergency contraceptive ‘morning after pill’ which is used to prevent unwanted pregnancy after unprotected intercourse. NorLevo contains only levonorgestrel as an active ingredient. The dosing is started within 72 hours after unprotected sexual intercourse.

Sosei has acquired the exclusive distribution rights to the product in Japan from HRA Pharma. The NDA is supported by the data from phase III study that was successfully completed in October 2008.

Sosei is a biopharmaceutical company with expertise in product discovery and development. It has established a reduced risk business model primarily upon identifying new uses for established drugs and exploiting its unique position within Japanese, European and North American pharmaceutical markets by acquiring compounds from, and bringing compounds into, Japan.