Mylan Inc. announced the United States launch of their generic formulation of GlaxoSmithKline’s Epivir-HBV® Lamivudine Tablets, 100 mg. The company received the FDA’s final approval for its Abbreviated New Drug Application (ANDA), appropriated for the treatment of chronic hepatitis B virus infection with evidence of active liver inflammation and hepatitis B viral replication.
According to the IMS Health, Lamivudine Tablets, 100 mg, registered about $18.1 million in sales in the United States for one year, ending September 30, 2014.
The use of Lamivudine, according to a press release, “has been associated with lactic acidosis and fatty liver disease. Acute exacerbations of Hepatitis B have occurred upon discontinuation. In patients with unrecognized or untreated HIV, resistance may emerge while treating Hepatitis B with Lamivudine.”
According to the IMS Health, Mylan has 284 ANDAs currently awaiting FDA approval, representing $109.1 billion in annual brand sales; “forty-four of these pending ANDAs are potential first-to-file opportunities, representing $29.3 billion in annual brand sales, for the 12 months ending June 30, 2014, according to IMS Health,” according to the press release.
Mylan is a pharmaceutical and global company focused on establishing new standards in health care. The company has several international bases, dedicated to providing 7 billion people access to high quality medicine, for less. The company supports its ideals in doing what is right instead of doing what is easy, to impact the future of healthcare and biomedical research through passion and top global leadership. The company currently offers more than 1,300 generic pharmaceuticals and a wide variety of brand medications.
Further, as it can be read in the press release: “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.” Mylan accounts more than 25,000 workers that are dedicated to improve the customer service and to increase the access to pharmaceuticals around the world.
In other developments on hepatitis B treatments, a new study reinforced previous evidence of neonatal HBV vaccination as a protective strategy against liver cancer and other chronic liver diseases in young adulthood. The study entitled “Efficacy of Neonatal HBV Vaccination on Liver Cancer and Other Liver Diseases over 30-Year Follow-up of the Qidong Hepatitis B Intervention Study: A Cluster Randomized Controlled Trial” was published in the journal PLOS Medicine.