US FDA issues drug safety communication on clozapine products

16 September 2015

The US Food and Drug Administration is making changes to the requirements for monitoring, prescribing, dispensing, and receiving the schizophrenia medicine clozapine, to address continuing safety concerns and current knowledge about a serious blood condition called severe neutropenia.

Severe neutropenia is a dangerously low number of neutrophils, white blood cells that help fight infections. Severe neutropenia can be life-threatening.

Manufacturers of approved clozapine medicines include HLS Therapeutics USA with its Clozaril brand, Jazz Pharmaceuticals (Nasdaq: JAZZ) with Versacloz, Sun Pharmaceutical Industries (SUN: BO), Teva Pharmaceutical (NYSE: TEVA) and Mylan (Nasdaq: MYL).

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