Prescription Drug User Fee Act (PDUFA)

FDA Delays Approval of neffy™ Intranasal Epinephrine Until September

Dave Bloom - 2023/06/20

The expected approval date has been delayed from mid-year.

FDA Schedules Review of neffy®, an Intranasal Alternative to Epinephrine Auto-Injectors

Dave Bloom - 2023/03/28

Meeting signals the FDA believes neffy has potential for approval given data gleaned from clinical trials.

FDA Accepts New Drug Application for Nasal Epinephrine Spray Treatment for...

Dave Bloom - 2022/10/21

If approved, acceptance targeted for mid-2023.

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Tag: Prescription Drug User Fee Act (PDUFA)

FDA Delays Approval of neffy™ Intranasal Epinephrine Until September

FDA Schedules Review of neffy®, an Intranasal Alternative to Epinephrine Auto-Injectors

FDA Accepts New Drug Application for Nasal Epinephrine Spray Treatment for...