Mylan’s generic of Allergan's vaginal estrogen cream Estrace gets FDA nod

Mylan has secured the US FDA approval for Estradiol Vaginal Cream USP, 0.01%, the generic version of Allergan’s vaginal estrogen cream – Estrace for the treatment of vulvar and vaginal atrophy.

Following the approval of the vaginal estrogen cream, Mylan has announced the launch of Estradiol Vaginal Cream in the US.

A condition that normally affects women after menopause, vaginal atrophy causes thinning and inflammation of the vaginal walls owing to lower levels of estrogen. The symptoms of vulvar and vaginal atrophy include dryness, itching and burning in and around the vagina.

Commenting on the FDA approval of Estradiol Vaginal Cream, Mylan CEO Heather Bresch said: “The approval and launch of Estradiol Vaginal Cream strengthens our robust women’s healthcare portfolio and our commitment to helping women manage their health across every stage of their lives, from contraception and hormone replacement therapy to certain disorders that are highly prevalent in women, like hypothyroidism.”

Mylan would offer Estradiol Vaginal Cream as an option to be used either as cream, gel, tablet or as a transdermal patch.

Mylan President Rajiv Malik, commenting on the FDA approval of Estradiol Vaginal Cream, said: “Topicals like Estradiol Vaginal Cream are a great example of Mylan’s ability to bring to market complex products. We have made substantial investments in research and development of these difficult-to-develop medicines and believe this provides long-term sustainability for our business.”