Mylan Launches Generic Combivir(R)
Product strengthens growing antiretroviral franchise in the U.S.
PITTSBURGH, Oct. 3, 2014 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced the U.S. launch of its Lamivudine and Zidovudine Tablets USP, 150 mg/300 mg, which is the generic version of Viiv's Combivir®. 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 HIV-1 infection in combination with other antiretroviral (ARV) agents.(1) Mylan has begun shipping this product, further strengthening the company's growing ARV portfolio in the U.S. market.
Lamivudine and Zidovudine Tablets USP, 150 mg/300 mg, had U.S. sales of approximately $118.5 million for the 12 months ending June 30, 2014, according to IMS Health.
Currently, Mylan has 288 ANDAs pending FDA approval representing $111.5 billion in annual brand sales, according to IMS Health. Forty-three of these pending ANDAs are potential first-to-file opportunities, representing $28.7 billion in annual brand sales, for the 12 months ending June 30, 2014, according to IMS Health.
Mylan is a global pharmaceutical company committed to setting new standards in health care. 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 1,300 generic pharmaceuticals and several brand medications. In addition, we offer a wide range of antiretroviral therapies, upon which approximately 40% of HIV/AIDS patients in developing countries depend. We also operate one of the largest active pharmaceutical ingredient manufacturers and currently market products in approximately 140 countries and territories. Our workforce of more than 20,000 people is dedicated to improving the customer experience and increasing pharmaceutical access to consumers around the world. Learn more at mylan.com.
(1) In people taking Lamivudine and Zidovudine Tablets, bone marrow problems, such as decreased production of red and/or white blood cells, can occur. Other potentially serious side effects are lactic acidosis, severe liver problems and myopathy (damage to the muscles, including the heart after prolonged use). Please see consult your healthcare provider for further safety information.
SOURCE Mylan Inc.