FDA Gives Tentative Approval for HIV Generic

11 August 2009 (Last Updated August 11th, 2009 18:30)

The US Food and Drug Administration (FDA) has granted tentative approval for a generic formulation of lamivudine tablets, an HIV treatment used in combination with antiretroviral agents. The treatment manufactured by Indian pharmaceutical company Strides Arcolab Limited will be available

The US Food and Drug Administration (FDA) has granted tentative approval for a generic formulation of lamivudine tablets, an HIV treatment used in combination with antiretroviral agents.

The treatment manufactured by Indian pharmaceutical company Strides Arcolab Limited will be available in 150mg and 300mg doses for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults.

The drug has only been granted "tentative approval" because although it has met all required quality, safety and efficacy standards, is not eligible for marketing in the US because of existing patent protections.

The product, however, is eligible for purchase outside of the US under the President's Emergency Plan for AIDS Relief programme.

Lamivudine is a generic formulation of Epivir tablets, 150mg and 300mg, a nucleoside reverse transcriptase inhibitor manufactured by GlaxoSmithKline.