Mylan N.V., a global pharmaceutical company committed to setting new standards in healthcare, has launched lamivudine tablets USP, 150 mg and 300 mg in US market. Lamivudine tablets is the generic version of ViiV Healthcare's Epivir tablets.
Mylan received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product. Lamivudine tablets is a nucleoside analogue reverse transcriptase inhibitor indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.
Lamivudine tablets USP, 150 mg and 300 mg, had US sales of approximately $27.1 million for the 12 months ending December 31, 2015, according to IMS Health.
Currently, Mylan has 265 ANDAs pending FDA approval representing $110.3 billion in annual brand sales, according to IMS Health. Forty-eight of these pending ANDAs are potential first-to-file opportunities, representing $38.3 billion in annual brand sales, for the 12 months ending December 31, 2015, according to IMS Health.