Germany’s Bayer said on Friday the U.S. health regulator has approved its drug for menopause relief.
The drug, branded as Lynkuet, is a non-hormonal treatment designed to relieve moderate-to-severe vasomotor symptoms, also known as hot flashes, associated with menopause.
The U.S. Food and Drug Administration’s approval was based on three late-stage studies that showed Lynkuet reduced the frequency and severity of hot flashes and eased sleep disturbances in menopausal women.
The regulator had in July extended the review of the drug, but did not raise any concerns regarding its general approvability.
