A panel of advisors to the Food and Drug Administration recommended that the agency reject a drug for hot flashes associated with menopause made by Hisamitsu Pharmaceutical Co Inc's subsidiary Noven Pharmaceuticals Inc.
The panel voted 10-4 against approval, with the majority saying the drug's benefit was not sufficient to offset its risks. The panel was evenly divided over whether the drug was in any way effective.
(Reporting By Toni Clarke. Editing by Andre Grenon)