UPDATE 1-FDA approves TherapeuticsMD’s hormone therapy

(Adds details on approval, background)

May 30 (Reuters) – The U.S. Food and Drug Administration (FDA) approved TherapeuticsMD Inc’s hormone therapy for a painful condition triggered by menopause, giving the women’s health company its first approved drug.

The treatment, Imvexxy, treats a symptom of vulvar and vaginal atrophy, a condition caused by the loss of female hormone estrogen after menopause.

The drug is delivered via a softgel capsule inserted into the vagina, distinguishing it from competing products including Allergan Plc’s Estrace cream and NovoNordisk’s Vagifem insert.

Safety warnings on Imvexxy’s label flag risks of endometrial cancer, cardiovascular disorders, breast cancer, and probable dementia.

Last year, the FDA declined to approve the drug, citing a requirement for long-term safety data, but allowed the company to apply for approval again without conducting a new study. (Reporting by Tamara Mathias in Bengaluru)

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