European Medicines Agency Accepts MAA Submission of Shionogi, Inc.'s Ospemifene for the Treatment of VVA
Published: Mar 27, 2013
LONDON--(BUSINESS WIRE)--Shionogi Limited, the London-based European subsidiary of Shionogi & Co., Ltd announced today that on 26th March 2013 the European Medicines Agency (EMA) accepted its Marketing Authorisation Application (MAA) submission for ospemifene for the treatment of vulvar and vaginal atrophy (VVA) in post-menopausal women. “We are pleased to announce the MAA submission for ospemifene to the EMA following the US Food and Drug Administration (FDA) approval last 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” said Takashi Takenoshita, CEO of Shionogi Limited.