7 source-based articles maintained by the HealthRX.com Editorial Team.
Showing 7 of 7 clinical reviews.
Is compounding flibanserin legal? A clinical breakdown of Addyi's FDA approval history, REMS requirements, 503A and 503B pharmacy rules, and what prescribers and patients need to know about compounded flibanserin access.
A clinical review of flibanserin (Addyi) safety signals reported through the FDA Adverse Event Reporting System (FAERS), including syncope, hypotension, and CNS depression data from post-market surveillance.
A clinical review of Addyi's FDA approval history, patent disputes, REMS modifications, and the legal battles that shaped flibanserin access for women with HSDD.
A clinical comparison of how the FDA approved Addyi (flibanserin) for HSDD while the EMA declined authorization, including trial data, safety requirements, and post-market changes.
A complete regulatory timeline of Addyi (flibanserin), including two FDA rejections, the 2015 approval, REMS requirements, labeling changes, and what the current prescribing label says about safety and dosing.
A comprehensive look at flibanserin (Addyi) regulatory history, FDA label requirements, REMS program, post-market safety data, and current availability outside the United States.
A cautious, source-checked look at how the FDA label and REMS program for Addyi (flibanserin) changed between 2020 and 2026, including the alcohol-warning revision and the 2023 REMS modification, with a note on which claims still need primary-source verification.