Posted by Michael Wonder on 11 Apr 2019
Cosmo Pharmaceuticals announces submission of remimazolam NDA TO FDA
9 April 2019 - Cosmo Pharmaceuticals today informed that the Remimazolam NDA has been submitted to FDA.
Electronic acknowledgment of the submission shows April 5 as the official date of submission. Therefore within 60 days, by June 4, FDA will communicate whether the NDA has been filed for review to proceed.
Remimazolam is an ultra-short-acting intravenous benzodiazepine sedative/anaesthetic that has shown positive results in clinical Phase III trials.
