The Food and Drug Administration rejected Amphastar Pharmaceuticals' application for an intranasal version of the opioid overdose antidote naloxone.
Amphastar on Tuesday received a complete response letter from the agency, which identified issues with a study assessing how humans interact with the device and device evaluation, among other concerns.
The drugmaker, which currently sells naloxone in pre-filled syringes, must address these issues with the nasal spray before resubmitting an application for FDA approval.
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