The product, a generic equivalent to Roche’s Boniva, is indicated for the treatment and prevention of osteoporosis in postmenopausal women.
Boniva had US sales of approximately $517m for the 12 months ending 31 December 2011 and currently Mylan has 173 ANDAs pending FDA approval representing $100.9bn in annual sales.
Mylan is a generic and specialty pharmaceutical company and provides products to customers in more than 150 countries and territories.