Drug Research
Drug Delivery

Mylan launches Estrace Cream generic after FDA approval

Published 02 January 2018

Mylan has launched Estradiol Vaginal Cream USP, 0.01%, the first generic version of Allergan's Estrace Cream, in the US.

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 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 is now one of only a few companies that will offer Estradiol as an option across four delivery systems – cream, gel, transdermal patch and tablet. This breadth allows us to deliver multiple options and, ultimately, greater value to customers, healthcare professionals and patients. Further, introducing a first-time generic demonstrates our leadership in continuing to create access to high quality medicine for patients and the U.S. healthcare system."

Mylan President Rajiv Malik added, "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."

Estrogens increase the risk of endometrial cancer, and should not be used for the prevention of cardiovascular disease or dementia. Estrogen use is associated with an increased risk of stroke, DVT and dementia in postmenopausal women. Because of the risks associated with estrogen use, they should be prescribed at the lowest effective dose and for the shortest duration.

Estradiol Vaginal Cream USP, 0.01%, had U.S. sales of approximately $449 million for the 12 months ending Oct. 31, 2017, according to IQVIA.

Currently, Mylan has 211 ANDAs pending FDA approval representing approximately $93.4 billion in annual brand sales, according to IQVIA. Forty-six of these pending ANDAs are potential first-to-file opportunities, representing $42.1 billion in annual brand sales, for the 12 months ending July 31, 2017, according to IQVIA.



Source: Company Press Release