Generics
FDA Approves Mylan Generic for Estrace Cream
2 January 2018 - - Hertfordshire, England-based global pharmaceutical company Mylan N.V. (NASDAQ: MYL) (TASE: MYL) has launched Estradiol Vaginal Cream USP, 0.01%, the first generic version of Allergan's Estrace Cream, in the US, the company said.
Mylan received final approval from the US Food and Drug Administration for its Abbreviated New Drug Application for this product, which is indicated in the treatment of vulvar and vaginal atrophy.
Estradiol Vaginal Cream USP, 0.01%, had US sales of approximately USD449 m for the 12 months ending Oct. 31, 2017, according to IQVIA.
Currently, Mylan has 211 ANDAs pending FDA approval representing approximately USD93.4 bn in annual brand sales, according to IQVIA.
Forty-six of these pending ANDAs are potential first-to-file opportunities, representing USD42.1 bn in annual brand sales, for the 12 months ending July 31, 2017, according to IQVIA.
Mylan offers a growing portfolio of more than 7,500 marketed products around the world, including antiretroviral therapies on which more than 40% of people being treated for HIV/AIDS globally depend. The company markets products in more than 165 countries and territories.
Login
Username:

Password: