Solvay Pharmaceuticals, Inc. announced that the US Food and Drug Administration (FDA) has approved EstroGel (estradiol gel), the first-ever estrogen therapy transdermal gel in the country for the treatment of moderate to severe vasomotor symptoms, as well as vulvar and vaginal atrophy associated with the menopause.
EstroGel is a clear, odorless, hydro-alcoholic gel that provides for delivery of estradiol for estrogen replacement in a non-patch transdermal form.
"With the approval of EstroGel, women and healthcare professionals now have an additional hormone therapy option. EstroGel will offer healthcare providers the opportunity to individualize a woman's therapy to help manage vasomotor symptom relief," said Harold Shlevin, CEO of Solvay. "The FDA's approval of EstroGel provides Solvay with a complete line of women's health products, offering women and their healthcare professionals a range of first and second-line menopausal therapeutic options, as well as adjunctive therapy for women requiring endometrial protection."
The only FDA approved estrogen therapy available in gel form, EstroGel provides women with a safe and easy-to-use treatment option. EstroGel has been a prescribed therapy for more than 25 years in Europe. It will be available with a prescription in pharmacies throughout the US by mid-year.