FDA re­jects Aca­ci­a's lead drug — again — due to the same man­u­fac­tur­ing is­sue

Aca­cia Phar­ma did well on the R&D front — by 2017, it had con­duct­ed four pos­i­tive piv­otal clin­i­cal tri­als for its lead drug, Barhem­sys. Lat­er that year, it sub­mit­ted an FDA ap­pli­ca­tion to mar­ket the drug for res­cue treat­ment of pa­tients who de­vel­op post­op­er­a­tive nau­sea & vom­it­ing (PONV), de­spite hav­ing been giv­en pri­or antiemet­ic pro­phy­lax­is — on­ly to re­ceive a re­jec­tion in Oc­to­ber 2018.

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