(Reuters) - The U.S. Food and Drug Administration approved Noven Therapeutics LLC's drug to treat hot flashes associated with menopause - a surprise decision as an advisory committee to the regulator had voted against its approval.
The drug, Brisdelle, is the first approved, non-hormonal treatment for hot flashes, the FDA said in a statement. ()
The label for Brisdelle, generically known as paroxetine, includes a boxed warning about suicidial thoughts.
Last month, the regulator rejected another non-hormonal therapy, Sefelsa, prompting its creator Depomed Inc to stop spending on the drug.
In March, advisers to the FDA voted against Brisdelle and Sefelsa, saying neither drug showed enough benefits to offset the risks.
Hot flashes, a symptom of menopause, occur in upto 75 percent of women, according to the FDA.
Hormone therapy was once a standard treatment to replace the hormones the body does not make after menopause, but its use dropped after 2002, when a large clinical trial showed the therapy increased the risk of heart disease and breast cancer.
Noven, a unit of Hisamitsu Pharmaceutical Co Inc, sells a higher dose of paroxetine as Pexeva to treat major depressive disorder, panic disorder and obsessive compulsive disorder. GlaxoSmithKline PLC markets a similar drug called Paxil.