Ospemifene is developed as as vulvar and vaginal atrophy (VVA) therapy in post-menopausal women.
Shionogi CEO Takashi Takenoshita said the US Food and Drug Administration has approved ospemifene previous month.
"The acceptance of the MAA submission for ospemifene not only represents an important step forward in expanding the treatment options for women living in Europe with this condition, but it is also an important milestone for Shionogi as it continues to build its business in Europe," Takenoshita added.