ZULRESSO

批准信原文要点

Your proposed modification to the REMS consists of an update to the REMS website to include a prominent static banner on the landing page containing the following statement: “As of January 1, 2025, ZULRESSO (brexanolone) will no longer be commercially available in the U.S.”

批准信原文要点

This “Changes Being Effected” supplemental new drug application provides for proposed modifications to the approved Zulresso (brexanolone) risk evaluation and mitigation strategy (REMS).

批准信原文要点

Your proposed modifications to the REMS consist of updating the hours of operations for the REMS call center, correcting a typographical error in the Healthcare Setting Knowledge Assessment, and requiring healthcare provider username and password for electronic submission of Post Infusion Form and Excessive Sedation and Loss of Consciousness Adverse Event Form.

批准信原文要点

This Prior Approval supplemental new drug application provides for expansion of the indication to include patients 15 years and older diagnosed with postpartum depression and addition of corresponding study information to applicable sections of the package insert, medication guide, and REMS.

批准信原文要点

This “Changes Being Effected” supplemental new drug application provides for proposed modifications to the approved Zulresso (brexanolone) risk evaluation and mitigation strategy (REMS).

批准信原文要点

Your proposed modifications to the REMS consist aligning language across REMS materials, adds a field to collect a DEA number on the Healthcare Setting Enrollment Form and Pharmacy Enrollment Form (following scheduling of Zulresso), adds a field to capture the scheduled infusion start date, and includes minor editorial changes.

批准信原文要点

This “Changes Being Effected” supplemental new drug application provides for revisions to the Prescribing Information, Medication Guide, and Carton and Container labeling to describe the scheduling of brexanolone.

批准信原文要点

Your proposed modifications to the REMS consist of aligning the pregnancy information in the Zulresso REMS materials (Patient Information Guide and Training for Healthcare Settings) with the approved Prescribing Information (PI) and Medication Guide (MG).