Zydus Lifesciences gets FDA final approval for Rapamune generic – Sirolimus Tablets

Zydus Lifesciences has secured final approval from the US Food and Drug Administration (FDA) for Sirolimus Tablets, 1 mg and 2 mg, which is the generic of anti-rejection medicine Rapamune Tablets.

Rapamune is indicated to prevent rejection in patients aged 13 and older who have undergone kidney transplants. It is also administered for the treatment of a rare lung disorder called lymphangioleiomyomatosis, which is mainly seen in women of childbearing age.

Zydus Lifesciences gets FDA final approval for Rapamune generic – Sirolimus Tablets. Photo courtesy of Zydus Cadila.

Sirolimus Tablets will be produced at Zydus Lifesciences’ manufacturing facility for formulations in Moraiya, Gujarat in India.

The annual sales of Rapamune are $69 million in the US, as per IQVIA MAT Dec. 2022.

Zydus Lifesciences currently has 342 approvals, and has submitted more than 440 abbreviated new drug applications (ANDAs) since the start of the filing procedure in the FY 2003-2004.