A New Drug Application as well as two supplemental New Drug Applications of Roche’s Xofluza are under FDA review, with a decision expected on November 23, 2020.Xofluza is already approved by the FDA to treat influenza in people 12 years of age and older who have had influenza symptoms for no more than 48 hours and is currently available in tablet formulation.The New Drug Application is seeking approval for a new formulation of Xofluza as one-dose granules for oral suspension and also for the treatment of acute uncomplicated influenza in otherwise healthy children aged one to less than 12 years of age who have been symptomatic for no more than 48 hours.The supplemental New Drug Applications are seeking approval to expand the indication of both the oral suspension and currently-available tablet formulation of Xofluza for post-exposure prophylaxis, potentially offering Xofluza as a preventive treatment for influenza after exposure to an infected individual.Xofluza brought in sales of 28 million Swiss Francs in the first nine months of 2020, up 286% over the comparable year-ago period.RHHBY.OB closed Friday’s (Oct.23, 2020) trading at $41.03, up 0.20%.