Monthly Prescribing Reference

Narcan Nasal Spray Gets Priority Review for OTC Treatment of Opioid Overdose

Credit: Getty Images. If approved, the OTC nasal spray would deliver 4mg of naloxone per spray. The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental New Drug ...
Monthly Prescribing Reference

Nasal Spray Formulation of Bumetanide Under FDA Review

A Prescription Drug User Fee Act target date of September 14, 2025 has been assigned to the application. The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) ...
Nasdaq

Amneal Pharma Says FDA Accepts For Review ANDA For Naloxone Hydrochloride Nasal Spray

(RTTNews) - Essential medicines company Amneal Pharmaceuticals, Inc. (AMRX) announced Thursday that the U.S. Food and Drug Administration (FDA) has accepted for review the Abbreviated New Drug ...
The Hill

Narcan maker says over-the-counter nasal spray fast-tracked by FDA

Emergent BioSolutions Inc., the maker of narcotic overdose treatment Narcan, said on Tuesday that the Food and Drug Administration (FDA) has accepted its application to grant priority review of its ...
Business Wire

Corstasis Therapeutics Inc. Announces FDA Acceptance of New Drug Application for Bumetanide Nasal Spray

HENDERSON, Nev.--(BUSINESS WIRE)--Corstasis Therapeutics Inc. (www.corstasis.com), a clinical-stage MedTech pharmaceutical company developing innovative, practical therapies for fluid overload, today ...