Zydus receives USFDA approval
Zydus Lifesciences secured approval from the US health regulator to market Darunavir Tablets, a generic antiviral for treating HIV-1 infection. The US Food and Drug Administration (USFDA) granted final approval for the medication, a protease inhibitor that curbs the multiplication of Human Immunodeficiency Virus (HIV-1) in adults and pediatric patients aged three and older. Co-administration with Ritonavir and other antiretroviral agents is necessary.
Manufactured at Zydus’ formulation facility in SEZ, Ahmedabad, Gujarat, the product addresses a significant market, with Darunavir tablets generating USD 275 million in annual sales in the US, as per IQVIA MAT data. The company’s shares were trading at Rs 645.95 apiece on the BSE, reflecting a 0.38% increase.
