Zydus Lifesciences gets final FDA nod for Darunavir for HIV-1 treatment

Drugmaker Zydus Lifesciences Limited announced on Friday that it has received the final nod from the United States Food and Drug Administration (USFDA) for Darunavir Tablets 600 mg and 800 mg, and tentative approval for 75 mg and 150 mg tablets. The company said in a media release that the drug will be made at the group’s formulation manufacturing facility in Zydus Special Economic Zone (SEZ), Ahmedabad.

Indicated for the treatment of Human Immunodeficiency Virus (HIV-1), Darunavir is a protease inhibitor antiviral medicine that stops HIV-1 from multiplying in the body. The drug is also indicated for the treatment of HIV-1 infection in pediatric patients three years of age and older. Darunavir must be co-administered with Ritonavir and with other antiretroviral agents.

According to market research firm IQVIA, Darunavir Tablets, 75 mg, 150 mg, 600 mg, and 800 mg had annual sales of $275 million in the US. Zydus now has 383 approvals and has so far filed over 440 abbreviated new drug applications (ANDAs) since the commencement of the filing process in the financial year 2003-04 (FY04). ANDAs contain data which is submitted to the FDA for the review and potential approval of a generic drug.

On Dec 1, Zydus said that it had received final approval from the USFDA for Ivabradine Tablets, 5 mg and 7.5 mg. Ivabradine assists in cutting the risk of hospitalisation for worsening heart failure in adult patients with stable, symptomatic chronic heart failure featuring reduced left ventricle ejection fraction.

Zydus Lifesciences saw a 53.3 jump in profit for the September quarter, led by robust sales in the domestic market and the US. Consolidated net profit was Rs 801 crore in the September quarter, compared with Rs 523 crore a year earlier. Total revenue from operations was up 9.1 per cent to Rs 4,369 crore.