Emergent Expects Moving OTC Naloxone Directions On Package To Sway US FDA Advisory Panel
Based on results from its study for switch NDA, with primary endpoint of users’ success in administering naloxone nasal spray, Emergent changes which DFl panels include the directions. FDA will tell advisory committee the firm has no study data validating effectiveness of changes.
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All members of a joint advisory panel noted an urgent need to expand naloxone access and voted yes on OTC sales of Emergent's Narcan nasal spray, but many also raised concerns about the testing needed for the DFl Facts label the firm unveiled during the meeting.
All members of joint advisory panel noted urgent need to expand access to naloxone and voted yes on OTC sales of Emergent's Narcan nasal spray, but many also pointed out concerns for testing needed for DFl Facts label firm unveiled to the panel as well as to FDA officials during meeting.
With the money coming in from monkeypox product Jynneos, the Danish firm has decided to pursue its goal of becoming one of the largest pure-play vaccine companies by acquiring jabs for cholera and typhoid from Emergent.