4 days ago
US FDA extends review of Bayer's menopause relief drug
July 25 (Reuters) - The U.S. Food and Drug Administration has extended its review of Bayer's ( opens new tab experimental menopause relief drug, the German drugmaker said on Friday.
The non-hormonal treatment, elinzanetant, is being reviewed for relieving moderate to severe vasomotor symptoms, also known as hot flashes, associated with menopause.
The FDA has extended the review by up to 90 days and did not raise any concern regarding the general approvability of the drug, Bayer said.
The drug, branded as Lynkuet, is approved in the United Kingdom and Canada.