Glenmark receives USFDA’s tentative approval for Ezetimibe

Glenmark Pharmaceuticals, a domestic pharma major, has informed BSE that Glenmark Generics — its US subsidiary — has received a tentative approval for cholesterol lowering agent Ezetimibe from US Food and Drug Administration (USFDA).

This is the first tentative approval granted by the USFDA for a generic version of the drug.

The launch of the product will be depended on the final approval for an Abbreviated New Drug Application (ANDA) filed with the USFDA.