Aurobindo Pharma, a Hyderabad-based manufacturer of generic pharmaceuticals and active pharmaceutical ingredients (APIs), has received tentative approval from the US Food and Drug Administration (USFDA) to manufacture and market Efavirenz tablets in 100mg strength.
This is Aurobindo’s 86th abbreviated new drug application (ANDA) approval – 61 final and 25 tentative – from the USFDA.
The new drug application provides for the use of Efavirenz tablets 100mg in combination with other antiretroviral agents and is indicated for the treatment of HIV infections, a company release said.
