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Five PDUFA dates on deck for July


Decisions from FDA due on a nasal naloxone and Sprycel competitor, among others

By Gunjan Ohri, Data Content Analyst

July 3, 2024 12:35 AM UTC

FDA has a light roster for the month of July, with at least five target action dates for three new medicines and label expansions for two.

A naloxone formulation from Orexo AB (SSE:ORX), OX124, has a PDUFA date of July 15. The high dose rescue nasal delivery medication uses amorphOX, a nasal powder technology that is stable when stored at elevated temperatures, while still being able to quickly dissolve. …