The U.S. Food and Drug Administration approved Opvee, the first nalmefene hydrochloride nasal spray for the emergency treatment of known or suspected opioid overdose in adults and pediatric patients 12 years of age and older
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Alert: NOxBOX Ltd. Issues Correction for NOxBOXi Nitric Oxide Delivery System Due to Risk for Nitric Oxide Dosing Fluctuations
There may be nitric oxide dosing fluctuations and therapy interruption when NOxBOXi Nitric Oxide Delivery System is used with certain ventilators.OMUFA Reauthorization: Fiscal Years 2026 – 2030
This page is the main website for information pertaining to OMUFA reauthorization activities, including high level meeting minutes with industry while negotiations are ongoing.Conducting Remote Regulatory Assessments Questions and Answers
Conducting Remote Regulatory Assessments Questions and Answers Guidance for IndustryPine Pharmaceuticals LLC. Tonawanda, NY. 483 issued 11/14/2025
Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 11/14/2025
Short Title (70 char) Pine Pharmaceuticals LLC. Tonawanda, NY. 483 issued 11/14/2025
FEI Number 3010943533
Firm Name Pine Pharmaceuticals LLC
Record Type 483
State NY
Establishment TypeFDA Roundup: July 14, 2023
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Over-the-Counter Monograph Drug User Fee annual performance reports to Congress
