FDA Approves Mylan's Copy of Allergan's Vaginal Cream

By Reuters Staff

January 02, 2018

(Reuters) - Mylan NV said the U.S. Food and Drug Administration had granted it the approval for a generic version of Allergan's Estrace cream for vaginal atrophy.

The approval comes amid the FDA's efforts to speed to market generic versions of complex drugs such as Mylan's own EpiPen, an emergency allergy shot.

Complex drugs include medicines like metered-dose inhalers to treat asthma that have at least one feature difficult to copy under existing rules.

Allergan's Estrace raked in annual sales of $379.4 million in 2016.

"Topicals like Estradiol Vaginal Cream are a great example of Mylan's ability to bring to market complex products," Mylan President Rajiv Malik said in a statement.

Vaginal atrophy, which usually occurs after menopause, results in thinning and inflammation of the vaginal walls due to less estrogen.