Approved Risk Evaluation and Mitigation Strategies (REMS)

Approved Risk Evaluation and Mitigation Strategies (REMS)

Contact Us | REMS Basics |  | Data Files

Addyi (flibanserin) 

NDA #022526 

REMS last update: 08/18/2015

View Addyi's Regulatory Information at Drugs@FDA

What do participants need to know?

Below is a general overview of the REMS for all REMS participants (e.g., patients, pharmacies, and healthcare providers). See the product-specific REMS website or the approved REMS materials for more information.

Healthcare Providers who prescribe Addyi must

Patients who are prescribed Addyi

Outpatient pharmacies that dispense Addyi must

Inpatient pharmacies that dispense Addyi must

Wholesalers that distribute Addyi must

What materials are included in the REMS?

The REMS includes a REMS Document. In addition, the REMS includes the following materials intended for patients and healthcare providers: