The US Food and Drug Administration (FDA) has granted tentative approval for a generic form of atazanavir sulfate, which is indicated for HIV-I infection treatment in adults in combination with other antiretroviral agents.

Tentative approval means that although the drug meets all the necessary safety, efficacy and manufacturing quality standards, existing patents prevent its marketing in the US. However, the drug qualifies for consideration for purchase under the President’s Emergency Plan for AIDS Relief.

The atazanavir sulfate generic is manufactured by Emcure Pharmaceuticals of Pune, India.