LCS 16 (levonorgestrel intrauterine device) filed in EU and US for contraception- Bayer HealthCare
Bayer HealthCare Pharmaceuticals has submitted a New Drug Application (NDA) to the FDA seeking approval for LCS 16, an investigational levonorgestrel intrauterine device (IUD) for pregnancy protection for up to five years. An application for marketing authorization for LCS 16 was submitted to the EMA in November 2015 for approval of the same indication in the European Union.
The FDA filing is based on data from the Phase III clinical trials which included 574 nulliparous and 878 parous women from North America and several European countries. The primary endpoint of the Phase III clinical trial program was contraceptive efficacy assessed by the Pearl Index.
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