FDA extends Clozapine REMS deadlines for prescribers, pharmacies
Dec. 14 is also the date for a pre-dispense authorization (PDA) deadline, a date that may be extended as well.
The REMS program replaced the six clozapine registries that were established by the manufacturers of the drug. The program mandates that prescribers, pharmacies and patients must enroll in one centralized place.
FDA officials encouraged health care providers to continue prescribing Clozapine, as needed. The drug is indicated for treatment of patients with an absolute neutrophil count -- a condition that may indicate inflammation, infection, stress, reaction to medication or the presence of cancer -- within acceptable ranges.
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U.S. Food and Drug Administration (FDA) 10903 New Hampshire Ave Silver Spring, MD 20903