Generic HIV Drug Launched

Mylan has launched lamivudine tablets USP, 150 mg and 300 mg, which are the equivalent of ViiV Healthcare’s Epivir tablets.

Lamivudine is a nucleoside analogue reverse transcriptase inhibitor designed to treat HIV-1 infection in combination with other antiretroviral agents.

Patients should be aware that the HIV treatment has been linked with lactic acidosis and fatty liver disease. In addition, patients who are coinfected with HIV and hepatitis B virus may have severe acute exacerbations of hepatitis B when they discontinue lamivudine.

The treatment had US sales of around $27 million for the fiscal year ending on December 31, 2015, according to IMS Health.

Mylan announced the FDA’s approval of its abbreviated new drug application (ANDA) on April 6, 2016.

To date, Mylan has 265 ANDAs pending with the FDA that are worth around $110 billion in annual brand sales.