FDA approves first generic version of Allergan's Estrace® estradiol vaginal cream

Global pharmaceutical giant  Mylan announced the U.S. launch of Estradiol Vaginal Cream USP, 0.01%, the first generic version of Allergan's Estrace® Cream. Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is indicated in the treatment of vulvar and vaginal atrophy.

Mylan is one of the few companies that have Estradiol as an option across four delivery systems – cream, gel, transdermal patch and tablet.

Mylan President Rajiv Malik added in a press release, "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."

Estradiol vaginal cream is often prescribed as topical treatment for postmenopausal vulvovaginal atrophy and had U.S. sales of approximately $449 million for the 12 months ending Oct. 31, 2017, according to IQVIA.

Mylan’s Press Release