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.
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. Nearly 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 $36.1bn in annual brand sales, for the 12 months ending June 30, 2015, according to IMS Health.