Zydus Lifesciences receives tentative approval from USFDA for Letermovir Tablets
Letermovir tablets are used to prevent disease caused by a virus called cytomegalovirus in people who have received a bone marrow transplant or kidney transplant.
Ahmedabad: Zydus Lifesciences Limited has announced that the Company has received tentative approval from the United States Food and Drug Administration (USFDA) to market Letermovir tablets, 240 mg and 480 mg, (USRLD: Prevymis tablets).
Letermovir tablets are used to prevent disease caused by a virus called cytomegalovirus (CMV) in people who have received a bone marrow transplant or kidney transplant.
Cytomegalovirus (CMV) is a common virus belonging to the herpesvirus family. It infects people of all ages worldwide. Once infected, the virus remains dormant in the body for life and can reactivate without causing symptoms. CMV spreads through bodily fluids, including saliva, blood, urine, semen, and breast milk. In healthy individuals, CMV infection often causes no noticeable symptoms or only mild symptoms resembling those of the flu, such as fever, fatigue, and muscle aches. However, CMV can cause serious complications in people with weakened immune systems, such as transplant recipients, people living with HIV/AIDS, and infants infected before birth (congenital CMV).
The drug will be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ, India.
Letermovir tablets, 240 mg and 480 mg had annual sales of USD 289.5 mn in the United States (IQVIA MAT Jan-24). The group now has 393 approvals and has so far filed over 460* ANDAs since the commencement of the filing process in FY 2003-04.
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Headquartered in Ahmedabad, Zydus Lifesciences Limited is an innovative, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The group has a significant presence in cancer related therapies and offers a wide range of solutions with cytotoxic, supportive & targeted drugs. The group employs over 26,000 people worldwide, including 1,400 scientists engaged in R & D.
