FDA removes REMS program for the antipsychotic drug clozapine

The US Food and Drug Administration (FDA) has removed the risk evaluation and mitigation strategy (REMS) for clozapine (currently marketed as Clozaril, Versacloz, and generics), effective June 13, 2025, the agency announced yesterday.

Clozapine, an antipsychotic medicine, can cause severe neutropenia (a low level of certain white blood cells), which can lead to serious and fatal infections.

Manufacturers of approved branded clozapine medicines include HLS Therapeutics USA with its Clozaril brand and Jazz Pharmaceuticals (Nasdaq: JAZZ) with Versacloz.