Zydus Lifesciences Limited announced that the company has received final approval from the United States Food and Drug Administration (USFDA) for Sirolimus Tablets (Rapamune Tablets), via an exchange filing.
The dosage limit approved is 1 mg and 2 mg of Rapamune Tablets.
Rapamune is used to prevent rejection (anti-rejection medicine) in people 13 years of age and older who have received a kidney transplant.
It is also given to treat a rare lung disorder called lymphangioleiomyomatosis which predominantly affects women of childbearing age.
The drug will be manufactured at the group’s formulation manufacturing facility at Moraiya.
Sirolimus Tablets had annual sales of USD 69mn in the United States (IQVIA MAT Dec. 2022).
The group now has 342 approvals and has so far filed over 440 ANDAs since the commencement of the filing process in FY 2003-04.
