FLORHAM PARK, N.J. — The Food and Drug Administration has accepted a regulatory approval application for a drug made by Shionogi for treating vulvar and vaginal atrophy due to menopause.
Shionogi, the U.S. division of Japanese drug maker Shionogi & Co., said Wednesday that the FDA had accepted for review its application for ospemifene, which the company touts as potentially the first oral alternative to vaginal estrogen treatments.