FDA-related information through March 2008 on C1 inhibitor, ferric carboxymaltose injection, lovastatin, carbidopa/levodopa extended release, vigabatrin, bortezomib, peginterferon alfa-2b, elesclomol, triphendiol, VQD-002
Complete response letter
Recommended for approval
Nonapprovable designations
Fast-track designations
Priority review
Orphan drug designations
FDA Issues Complete Response for High-Dose Opioid Rescue Med
July 16th 2024OX124 is a nasal spray provides rapid absorption of naloxone for patients experiencing an opioid overdose. The FDA would like to see additional technical data, as well as data on whether patients can correctly use the device.
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