Mylan Inc., a global pharmaceutical company committed to setting new standards in health care, has launched lamivudine and zidovudine tablets USP, 150 mg/300 mg in US markets, which is the generic version of Viiv's Combivir.
Mylan received final approval from the US 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. Mylan has begun shipping this product, further strengthening the company's growing ARV portfolio in the US market.
Lamivudine and zidovudine tablets USP, 150 mg/300 mg, had US 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.