Posted by Michael Wonder on 25 Oct 2018
Duchesnay announces submission of supplemental new drug application for Osphena (ospemifene) to U.S. FDA seeking approval for the treatment of vaginal dryness, a symptom of vulvar and vaginal atrophy due to menopause
23 October 2018 - Duchesnay announced today that it has submitted a supplemental new drug application to the U.S. FDA seeking a new indication for Osphena (ospemifene).
Osphena received FDA approval for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy due to menopause, in February 2013. The company is currently seeking FDA approval to add the indication of moderate to severe vaginal dryness, also a common symptom of vulvar and vaginal atrophy due to menopause.
