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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.
"Women spend more than a third of their lives in menopause, yet VVA is an underdiagnosed and underrated condition that significantly impacts the health and well-being of women," Shionogi president and CEO John Keller said.