I reached out to Eden and did not get a response (yet)
www.fda.gov/news-events/press-announcements/fda-approves-new-drug-treatment-chronic-weight-management-first-2014 Available at: (accessed 26 June 2023)
The NDA includes all the clinical trial data, the safety reports, and the manufacturing plans
This article reviews current evidence, potential mechanisms, and practical guidance for patients and healthcare providers
However, since furosemide has a broad therapeutic index and is generally dose-adjusted individually, and since rosuvastatin is generally well-tolerated with similar increases in exposures previously being reported as not clinically relevant, the results observed in the present trial are expected to be of no clinical relevance
Promotional transparency matters more than hype