HERTFORDSHIRE, England and PITTSBURGH, March 10, 2017 /PRNewswire/ -- Mylan N.V. (NASDAQ, TASE: MYL), today announced the U.S. launch of Desvenlafaxine Extended-release Tablets, 50 mg and 100 mg, a generic version of Pfizer's Pristiq® Tablets. Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is indicated for the treatment of major depressive disorder. (1)
Desvenlafaxine Extended-release Tablets, 50 mg and 100 mg, had U.S. sales of approximately $853 million for the 12 months ending January 31, 2017, according to IMS Health.
Currently, Mylan has 241 ANDAs pending FDA approval representing approximately $100.9 billion in annual brand sales, according to IMS Health. Forty-five of these pending ANDAs are potential first-to-file opportunities, representing $39 billion in annual brand sales, for the 12 months ending December 31, 2016, 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 approximately 7,500 marketed products around the world, including antiretroviral therapies on which approximately 50% of people being treated for HIV/AIDS in the developing world 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 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.
(1) Antidepressants can increase the risk of suicidal thinking and behavior in children, adolescents and young adults. Monitor for worsening and emergence of suicidal thoughts and behaviors. This medicine is not approved for use in pediatric patients.
SOURCE Mylan N.V.