usfda: Zydus gets USFDA nod for antiviral drug used in HIV treatment

Zydus Lifesciences on Friday said it has received approval from the US health regulator to market a generic antiviral medication used in the treatment of HIV-1 infection. The company has received final approval from the US Food and Drug Administration (USFDA) for Darunavir Tablets, the company said in a statement.

Darunavir is a protease inhibitor antiviral medicine that prevents Human Immunodeficiency Virus (HIV-1) from multiplying in the body.

It is indicated for the treatment of HIV-1 infection in adult patients. It is also indicated for the treatment of HIV-1 infection in pediatric patients three years of age and older.

It must be co-administered with Ritonavir and with other antiretroviral agents.

Zydus said the product will be manufactured at the group’s formulation manufacturing facility in SEZ, Ahmedabad, Gujarat.

As per IQVIA MAT data, Darunavir tablets (75 mg, 150 mg, 600 mg, and 800 mg) had annual sales of USD 275 million in the US. Shares of the company were trading 0.38 per cent higher at Rs 645.95 apiece on the BSE.