The FDA green-lighted Byfavo (remimazolam), developed by Cosmo Pharmaceuticals N.V. (0RGI.L), on July 2, 2020, for the induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less.Byfavo, which was in-licensed from Germany’s Paion in June 2016, was sub-licensed by Cosmo to Acacia Pharma Group in January this year.Byfavo is expected to bring in peak sales of $126 million, estimate analysts.The drug comes with a Boxed Warning regarding appropriate training of personnel and equipment that must be available when administering it, during sedation and during the recovery period of the procedure and about the risks associated with the concomitant use of BYFAVO with opioid analgesics and other sedative hypnotics. Acacia revealed that Byfavo may not be marketed in the US until the Drug Enforcement Administration has determined its scheduling under the Controlled Substances Act, which is expected to take place within the next few months.