Mayne Pharma Group Receives US FDA Confirmation on Fulfillment of Post-Marketing Requirement for Vaginal Inserts
MT Newswires Live
Oct 09
Mayne Pharma Group (ASX:MYX) received a letter from the US Food and Drug Administration (FDA) confirming the company's fulfillment of its post-marketing requirement safety study for IMVEXXY vaginal inserts, according to a Friday filing with the Australian bourse.
IMVEXXY is approved by the FDA for the treatment of moderate-to-severe dyspareunia, a symptom of vulvar and vaginal atrophy due to menopause, the filing said.
The study showed that there's no link between very-low-dose vaginal estrogen products and endometrial cancer risk in postmenopausal women, per the filing.
Shares fell 2% in morning trade Friday.
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