
The Clozapine REMS program has notified all prescribers registered with the system that the clozapine manufacturers have formally replied to the FDA announcement of 2/24/2025. The reply included a modification to eliminate the Clozapine REMS and update the prescribing information for clozapine. Upon FDA request, they have also developed a Medication Guide for patients which will be available pending FDA approval. They anticipate that the FDA will approve this modification in mid-June of 2025. The REMS Program emphasized that the newclozapinerems.com website will cease to operate upon the FDA’s acceptance of the modification. AAPP will be communicating this new information to pharmacy associations and other relevant stakeholders in order that they may fully understand the ramifications of this information.