HERTFORDSHIRE, England and PITTSBURGH, July 20, 2016 /PRNewswire/ -- Mylan N.V. (NASDAQ, TASE: MYL) today announced the U.S. launch of Rosuvastatin Calcium Tablets, 5 mg, 10 mg, 20 mg and 40 mg, which is a generic version of AstraZeneca's Crestor®. Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product. Rosuvastatin Calcium Tablets are used in combination with diet for the treatment of high triglycerides (hypertriglyceridemia) in adults.
Rosuvastatin Calcium Tablets, 5 mg, 10 mg, 20 mg and 40 mg, had U.S. sales of approximately $6.7 billion for the 12 months ending May 31, 2016, according to IMS Health.
Currently, Mylan has 245 ANDAs pending FDA approval representing $101.6 billion in annual brand sales, according to IMS Health. Forty-one of these pending ANDAs are potential first-to-file opportunities, representing $30.8 in annual brand sales, for the 12 months ending December 31, 2015, according to IMS Health.
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 1,400 generic and branded pharmaceuticals, including antiretroviral therapies on which approximately 50% of people being treated for HIV/AIDS in the developing world depend. We market our products in approximately 165 countries and territories. Our global R&D and manufacturing platform includes more than 50 facilities, and we are one of the world's largest producers of active pharmaceutical ingredients. Every member of our more than 35,000-strong workforce is dedicated to creating better health for a better world, one person at a time. Learn more at mylan.com.
SOURCE Mylan N.V.