24th Nov 2015 17:09
LONDON (Alliance News) - Indivior PLC said Tuesday that the US Food and Drug Administration has not to approved its new drug application for naloxone nasal spray for the treatment of opioid overdose.
The FDA's response letter was focused on clinical pharmacology that found that early stage uptake of naloxone nasal spray did not fully meet the FDA's threshold. Indivior said it is evaluating the FDA's comments to determine its next steps to address the FDA's findings.
"We are closely reviewing the FDA's response. Our commitment to improving patient outcomes remains steadfast, and as part of this, our work with stakeholders across communities will continue," said Chief Executive Officer Shaun Thaxter.
Shares in Indivior closed down 0.9% at 195.00 pence Tuesday.
By Hana Stewart-Smith; [email protected]; @HanaSSAllNews
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