Industry Briefs
FDA Extends Deadlines for Clozapine REMS Program
The Food and Drug Administration (FDA) has extended the deadlines for prescribers and pharmacies to complete their required online Clozapine Risk Evaluation and Mitigation Strategy (REMS) certification to ensure health providers have adequate time to complete this process and patient access to clozapine is maintained.
“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,” the agency stated in an announcement issued on November 19. According to the FDA, updated deadlines will be released as soon as possible.
FDA Drug Shortages, Discontinuation List Includes Six Psychotropic Drugs
Pharmaceutical manufacturers have reported that the following psychotropic medicines have been discontinued or are in short supply.
Discontinued:
Oral solution 1 mg/mL
Discmelt orally disintegrating tablets (10 mg and 15 mg)
Injection for intramuscular use only (9.75 mg/1.3 mL [7.5 mg/mL])
2 mg/mL; 1 mL iSecure syringe
In short supply:
Haloperidol lactate injection
Methylin chewable tablets
Methylphenidate hydrochloride ER capsules/tablets
Surmontil ( Trimipramine maleate capsules)
To stay current on drug discontinuations and shortages, visit the FDA Drug Shortage website. ■
