Zydus Lifesciences, on 15 December, announced that it had received approval from the USFDA (US Food and Drug Administration) to market a generic antiviral medication used in the treatment of HIV-1 infection.

In its regulatory filing, the company said that it has received final approval from the USFDA for Darunavir Tablets 600 mg and 800 mg and has also received tentative approval for 75 mg and 150 mg tablets.

Darunavir is a protease inhibitor antiviral medicine that prevents the human immunodeficiency virus (HIV-1) from multiplying in the body.

It is used for the treatment of HIV-1 infection in adult patients and is also used for the treatment of HIV-1 infection in paediatric patients three years of age and older. The tablets have to be co-administered with Ritonavir and with other antiretroviral agents.

The tablets will be manufactured at the company’s formulation manufacturing facility in SEZ, Ahmedabad.

The Darunavir tablets have annual sales of $275 million in the US, according to IQVIA MAT data.