FDA-related information through February 2008 on Fluvoxamine extended-release capsules, dalbavancin, bazedoxifene, HPV vaccine (Cervarix), valrubicin, motexafin gadolinium, COL-003, CDX-110, sugammadex, mecaserim rinfabate, A-001, beclomethasone, clobazam, fludarabine tablets, JZP-8, and AST-120
Approvable designations
Complete response letter
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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