Af­ter steer­ing through a con­tro­ver­sy over soar­ing price of nalox­one, FDA re­jects Am­phastar’s in­tranasal ver­sion

Af­ter com­ing un­der fire from an­gry law­mak­ers in the wake of its re­cent de­ci­sion to more than dou­ble the price of its opi­oid in­ter­ven­tion drug nalox­one, Am­phastar $AMPH says that the FDA has hand­ed it a re­jec­tion for an in­tranasal ver­sion of the treat­ment.

The biotech didn’t spell out all the rea­sons for the re­jec­tion or go in­to much de­tail in its state­ment, but the com­pa­ny cit­ed the agency’s ques­tions about a “user hu­man fac­tors study, de­vice eval­u­a­tion, and oth­er items.”

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