FDA clears Glenmark’s generic Rapamune tablets

The Food and Drug Administration has approved Glenmark Pharmaceuticals’ sirolimus tablets, a generic of Rapamune. Glenmark’s generic was approved in 0.5-, 1- and 2-mg dosage strengths. 

The drug is an immunosuppressant indicated to prevent organ rejection in patients 13 years old and older receiving liver transplants. It also is indicated to treat patients with lymphangioleiomyomatosis. 

The product had annual sales of $119.7 million for the year ended August 2020, according to IQVIA data.