WHIPPANY, N.J., Nov. 20, 2015 /PRNewswire/ -- Bayer HealthCare Pharmaceuticals announced today that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration seeking approval for LCS-16, an investigational hormonal intrauterine device (IUD) for pregnancy protection for up to five years.
The submission 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
"As a global leader in Women's Healthcare, Bayer is committed to the continuous advancement of our portfolio of contraceptive methods to help meet the needs of a broad range of women," said Dario Mirski, M.D., vice president and head of U.S. medical affairs at Bayer. "With this submission, we hope to offer women an additional long-acting reversible contraception for up to five years."
LCS-16 is an investigational agent and is not approved by the U.S. FDA, the European Medicines Agency (EMA) or other health authorities. 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.
LCS-16 is an investigational intrauterine device (IUD) containing 19.5 mg of a progestin hormone called levonorgestrel. The NDA has been submitted to the FDA to seek approval for use to prevent pregnancy for up to five years.
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SOURCE Bayer HealthCare Pharmaceuticals