Zydus Lifesciences receives US approval for generic HIV-1 drug
Zydus Lifesciences has secured final approval from the US Food and Drug Administration (USFDA), to market its generic Darunavir tablets in the country. It is an antiviral medication essential for treating Human Immunodeficiency Virus (HIV-1) infection. As a protease inhibitor, Darunavir works by preventing HIV-1 from multiplying within the body, making it a vital component in HIV therapy.
Darunavir tablets are for patients three years old and above
The USFDA has approved Darunavir tablets for treating HIV-1 infection in adults and pediatric patients aged three years and older. For optimal effectiveness, Darunavir must be administered alongside Ritonavir and other antiretroviral agents. This approval signifies a major advancement in offering accessible treatment options for individuals affected by HIV-1 in the US.
Manufacturing and market impact
According to Zydus, the Darunavir tablets will be produced at the company's formulation manufacturing factory in SEZ, Ahmedabad. Based on IQVIA MAT data, Darunavir tablets of 75mg, 150mg, 600mg, and 800mg) generated yearly sales of $275 million in the US. Following this announcement, Zydus Lifesciences's shares experienced a 0.38% increase, closing at Rs. 645.95 apiece on the BSE.
