Mylan introduces Estrace cream generic

Mylan has announced the launch of its Estradiol Vaginal Cream USP, 0.01%, the first generic version of Allergan's Estrace cream. The company received final approval from the U.S. Food and Drug Administration for the product which is intended to treat vulvar and vaginal atrophy.

“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 CEO, Heather Bresch said.

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