FDA OKs Hisamitsu Pharmaceutical's First Nonhormonal Drug for Hot Flashes

Published: Jul 02, 2013

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Hisamitsu Pharmaceutical Co. (4530)’s Noven unit won U.S. approval for its drug to ease hot flashes associated with menopause.

The Food and Drug Administration said today it cleared the drug, to be called Brisdelle, as the first non-hormonal alternative approved to help women avoid sweating and feverish feelings linked to menopause. The active ingredient in the treatment, paroxetine, is currently sold in the U.S. by Saga, Japan-based Hisamitsu’s Noven Pharmaceuticals unit as Pexeva for depression, panic disorder and other conditions.

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