Surfactant replacement therapy (Surfaxin, Discovery Laboratories) for the prevention of respiratory distress syndrome (RDS) in premature infants
Approvable designations
Priority review
Fast-track designations
Nonapprovable designations
Recommendations against approval
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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