FDA data request slows progress of new fentanyl stopper
Swedish drugmaker Orexo (STO:ORX) has been struck by an unexpected delay in its bid to register a high-dose naloxone rescue medication in the USA.
The firm has received a complete response letter (CRL) from the US Food and Drug Administration, highlighting the need for an additional “human factors” study.
The agency has also asked for more technical data on the final commercial product. No further clinical or non-clinical studies are required.
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