Zydus Cadila gets tentative nod from USFDA to market HIV drug

Zydus Cadila on Thursday said it has received a tentative nod from the US health regulator to market Emtricitabine and Tenofovir Disoproxil Fumarate tablets used for controlling human immunodeficiency virus (HIV) infection, in America.

The company has received tentative approval from the United States Food and Drug Administration (USFDA) to market Emtricitabine and Tenofovir Disoproxil Fumarate tablets 100 mg/150 mg, 133 mg/200 mg and 167 mg/250 mg, Zydus Cadila said in a statement. The drug will be manufactured at the group’s formulation manufacturing facility at the SEZ Ahmedabad, it added.

The tablets are used with other HIV medications to help control HIV infection, Zydus Cadila said. The group now has 312 approvals and has so far filed over 400 abbreviated new drug applications (ANDAs) since the commencement of its filing process, it added.