HERTFORDSHIRE, England and PITTSBURGH, Oct. 18, 2018 /PRNewswire/ -- Global pharmaceutical company Mylan N.V. (NASDAQ: MYL) today announced the U.S. launch of Medroxyprogesterone Acetate Injectable Suspension USP, 150 mg/mL Single-Dose Vial, a generic version of the brand drug, Pfizer's Depo-Provera®.
Mylan is offering Medroxyprogesterone Acetate Injectable Suspension USP, 150 mg/mL Single-Dose Vial to its institutional customers after an Abbreviated New Drug Application (ANDA) for the product was approved by the U.S. Food and Drug Administration (FDA). Medroxyprogesterone Acetate Injectable (MPA) is indicated in the prevention of pregnancy.
Mylan CEO Heather Bresch said, "The launch of Medroxyprogesterone Acetate adds to Mylan's robust portfolio of generic birth control medicines in the U.S. These products are part of Mylan's growing women's healthcare offerings, which include a variety of medicines to help women manage their health across all the stages of their lives."
Women who use MPA may lose significant bone mineral density. Bone loss is greater with increasing duration of use and may not be completely reversible. It is unknown if use of MPA during adolescence or early adulthood, a critical period of bone accretion, will reduce peak bone mass and increase the risk for osteoporotic fracture in later life. MPA should not be used as a long-term birth control method (i.e., longer than 2 years) unless other birth control methods are considered inadequate.
U.S. sales for MPA were approximately $181 million for the 12 months ending July 31, 2018, according to IQVIA.
Currently, Mylan has 179 ANDAs pending FDA approval representing approximately $89.3 billion in annual brand sales, according to IQVIA. Forty-four of these pending ANDAs are potential first-to-file opportunities, representing $51.6 billion in annual brand sales, for the 12 months ending June 30, 2018, according to IQVIA.
Mylan is a global pharmaceutical company committed to setting new standards in healthcare. Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy unmet needs; make reliability and service excellence a habit; do what's right, not what's easy; and impact the future through passionate global leadership. We offer 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. We market our products in more than 165 countries and territories. We are one of the world's largest producers of active pharmaceutical ingredients. Every member of our approximately 35,000-strong workforce is dedicated to creating better health for a better world, one person at a time. Learn more at Mylan.com. We routinely post information that may be important to investors on our website at investor.mylan.com.
SOURCE Mylan N.V.