$ADMP interesting comment on CMC by Stockparty on Yahoo messag board; “see that the barrel contains the bolus of injectable Zimhi naloxone. The syringe is the same so up until they put the dose of Zimhi into the syringe it is assumed clean. Likewise for the naloxone itself. So there can be only one or both of 2 issues. Issue 1: act of dispensing the naloxone dose into the syringe needs to be proven clean and free of pathogens, and / or Issue 2: the higher concentration naloxone dose requires an updated package insert. I would think that given the toxicology report and with their current manufacturing expertise these are very solvable.”
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