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US FDA gives mixed review for Depomed, Noven hot flash drugs

This article was originally published in Scrip

Executive Summary

While suicidality was the greatest safety concern for the FDA in its reviews of Depomed's and Noven Pharmaceuticals’ experimental medicines for treating moderate-to-severe menopausal-related hot flashes and night sweats, a condition known as vasomotor symptoms (VMS), agency reviewers noted that risk already is known about the active ingredients in both drugs, with the scientists raising only moderate concerns about other adverse events (AEs) in the companies' studies.



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