The US Health Authority FDA takes more time to check the Menopause drug Elinzanant from Bayer.
The FDA had accepted the application for approval for Elinzanant to treat hot flashes in women in the menopause in October last year. Now the authority informed the German Dax Group that they need additional time for a complete review, including information provided to support the application. The extension of the examination period is up to 90 days, Bayer said. The FDA had no concerns about the general approval of Elinzanant.
The medication has already been approved in the United Kingdom and Canada under the brand name Lynkuet within the last thirty days. Applications for market registrations for Elinzanant in the EU and other markets worldwide are currently being examined. Elinzanant is considered a possible blockbuster.
The Bayer share is robust in the post-exchange tradegate trade on Friday and temporarily gains 0.71 percent to EUR 29.21.
Dow Jones
Selected leverage products on Bayer
With knock-outs, speculative investors can participate disproportionately in price movements. Simply choose the desired lever and we will show you suitable open-end products on Bayer
The lever must be between 2 and 20
Advertising