FDA gives tentative nod to Zydus Cadila's generic Truvada

Zydus Cadila has received tentative approval from the Food and Drug Administration for emtricitabine and tenofovir disoproxil fumarate tablets in dosage strengths of 100 mg/150 mg, 133 mg/200 mg and 167 mg/250 mg.

The product is the generic of Gilead's Truvada.

The medication is used with other HIV medications to help control HIV infection. This product is a combination of emtricitabine and tenofovir disoproxil fumarate and helps to decrease the amount of HIV in the body so that the immune system can work better.

The drug will be manufactured at the group’s formulation manufacturing facility at SEZ, Ahmedabad.