Due to ongoing implementation challenges with the new Clozapine REMS Program, the FDA is extending the November 23, 2015 prescriber certification deadline and the December 14, 2015 pharmacy certification deadline to help ensure that healthcare professionals have sufficient time to complete this process and that patient access to clozapine is maintained.
In addition to the deadline extensions, the FDA is also evaluating next steps regarding the December 14, 2015 pre-dispense authorization (PDA) launch. Healthcare providers are recommended to continue prescribing and dispensing clozapine to patients with an acceptable absolute neutrophil count (ANC) as the issues are being resolved by the Clozapine REMS administrators. Both the pharmacies and prescribers are encouraged to work with the Program administrators to resolve any ongoing issues and make efforts to complete certification and update patient information as required by the REMS program.
The FDA will announce the revised certification deadlines and more information about the PDA launch as soon as possible.
Clozapine is an atypical antipsychotic indicated for treatment resistant schizophrenia and to reduce risk of recurrent suicidal behavior in schizophrenia or schizoaffective disorders.
For more information call (888) 463-6322 or visit FDA.gov.