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01.05.2013 | R&D Insight Report

Ospemifene: First Global Approval

verfasst von: Shelley Elkinson, Lily P. H. Yang

Erschienen in: Drugs | Ausgabe 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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Titel: Ospemifene: First Global Approval
verfasst von: Shelley Elkinson
Lily P. H. Yang
Publikationsdatum: 01.05.2013
Verlag: Springer International Publishing AG
Erschienen in: Drugs / Ausgabe 6/2013
Print ISSN: 0012-6667
Elektronische ISSN: 1179-1950
DOI: https://doi.org/10.1007/s40265-013-0046-y

Springer Medizin

Abstract

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