Mylan adds to U.S. women’s healthcare portfolio with FDA approval of first generic for Esterase cream.
Mylan N.V. on Friday 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 the product, which is indicated in the treatment of 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 CEO Heather Bresch said. “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.”
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: Mylan N.V.)
Filed Under: Drug Discovery