FDA delays certification deadlines for Clozapine REMS Program

The Food and Drug Administration yesterday extended the prescriber and pharmacy certification deadlines for the new Clozapine Risk Evaluation and Mitigation Strategy Program, citing ongoing implementation challenges. “We will communicate the revised certification deadlines and additional information about the [pre-dispense authorization] launch as soon as possible,” the agency said. “Health care providers should prioritize the medical needs of their patients and, as appropriate, continue prescribing and dispensing clozapine to patients with an absolute neutrophil count within the acceptable ranges while the issues are being resolved by the Clozapine REMS program administrators.” In September, FDA announced changes to the requirements for monitoring, prescribing, dispensing and receiving the schizophrenia medicine to address continuing safety concerns about a serious blood condition called severe neutropenia.