Bleeding rates associated with new use of dabigatran (Pradaxa, Boehringer Ingelheim) do not appear to be higher than bleeding rates associated with new use of warfarin, according to an FDA safety review of post-market reports of serious bleeding events.
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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