Sedana Medical AB (publ), a medical device company, announced a positive top line result for the company's pivotal phase III study, IsoConDa. The study reached its primary endpoint; to show that IsoConDa (isoflurane), administered with AnaConDa, is an effective sedation method, for ventilator-intensive care patients, which is non-inferior to propofol.
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 10 abbreviated new drug applications (ANDAs) from multiple applicants.