Zydus Lifesciences Receives Tentative Approval from USFDA for Letermovir Tablets, 240 mg and 480 mg

Zydus Lifesciences Limited has received tentative approval from the USFDA to market Letermovir tablets, 240 mg and 480 mg in the United States. The drugs are used to prevent disease caused by cytomegalovirus in bone marrow and kidney transplant patients. The group's formulation manufacturing facility at Ahmedabad, India, will manufacture these tablets. The annual sales of Letermovir tablets in the US were USD 289.5 mn in 2023. Zydus now has a total of 393 approvals and has filed over 460 ANDAs since the commencement of the filing process in FY 2003-04.