Five PDUFA dates on deck for July

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. ...