Mylan Launches Generic Viramune XR® Extended-Release Tablets, 100 mg

Nov 16, 2015, 07:30 ET from Mylan N.V.

HERTFORDSHIRE, England and PITTSBURGH, Nov. 16, 2015 /PRNewswire/ -- Mylan N.V. (NASDAQ, TASE: MYL), today announced the U.S. launch of Nevirapine Extended-release Tablets, 100 mg, the generic version of Boehringer Ingelheim's Viramune XR®. 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 used in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and in children 6 to less than 18 years of age.(1) The launch adds to Mylan's growing portfolio of ARV medicines across the globe, and represents the company's continued commitment to stem the tide of HIV/AIDS. Approximately 50% of those being treated for HIV/AIDS in the developing world, for example, rely on a Mylan product.

Nevirapine Extended-release Tablets, 100 mg, had U.S. sales of approximately $67 thousand for the 12 months ending Sept. 30, 2015, according to IMS Health.

Currently, Mylan has 253 ANDAs pending FDA approval representing $100.8 billion in annual brand sales, according to IMS Health. Fifty of these pending ANDAs are potential first-to-file opportunities, representing $36.1 billion in annual brand sales, for the 12 months ending June 30, 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 around 1,400 generic pharmaceuticals and several brand medications. In addition, we offer a wide range of antiretroviral therapies, upon which nearly 50% of HIV/AIDS patients in developing countries depend. We also operate one of the largest active pharmaceutical ingredient manufacturers and currently market products in about 145 countries and territories. Our workforce of approximately 30,000 people is dedicated to creating better health for a better world, one person at a time. Learn more at mylan.com.

(1) Severe, life-threatening, and in some cases fatal liver toxicity and skin reactions have been reported with the use of Nevirapine Extended-release tablets. Monitoring by your healthcare provider is essential during the first 18 weeks of therapy.

SOURCE Mylan N.V.



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