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Published in: Drugs 6/2013

01-05-2013 | R&D Insight Report

Ospemifene: First Global Approval

Authors: Shelley Elkinson, Lily P. H. Yang

Published in: Drugs | Issue 6/2013

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Abstract

Ospemifene (Osphena™) is an oral selective estrogen receptor modulator (SERM), with tissue-specific estrogenic agonist/antagonist effects. QuatRx Pharmaceuticals conducted the global development of the agent before licensing it to Shionogi for regulatory filing and commercialization worldwide. Ospemifene is the first non-estrogen treatment approved for moderate to severe dyspareunia in women with menopause-related vulvar and vaginal atrophy. The drug is approved in the USA, and application for EU regulatory approval is underway. This article summarizes the milestones in the development of ospemifene leading to this first approval for moderate to severe dyspareunia, a symptom of postmenopausal vulvar and vaginal atrophy.
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Metadata
Title
Ospemifene: First Global Approval
Authors
Shelley Elkinson
Lily P. H. Yang
Publication date
01-05-2013
Publisher
Springer International Publishing AG
Published in
Drugs / Issue 6/2013
Print ISSN: 0012-6667
Electronic ISSN: 1179-1950
DOI
https://doi.org/10.1007/s40265-013-0046-y

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