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Rx Naloxone Marketer's OTC Switch Proposal For Nasal Spray Gets Priority Review From FDA

 
• By Malcolm Spicer

Emergent BioSolutions’ announcement of FDA accepting sNDA for an OTC 4-mg naloxone nasal spray marks another recent step in agency’s response under Commissioner Califf to Capitol Hill pressure to expand availability of topioid antagonist to help curb opioid overdose death epidemic.

With priority review granted for Emergent's sNDA for OTC Narcan nasal spay. FDA’s deadline under PDUFA for a decision is 29 March. • Source: Shutterstock

The US Food and Drug Administration is on the clock for a decision on an application for OTC naloxone before April 2023 after designating for priority review a proposal submitted by the marketer of Narcan, the Rx brand synonymous with the opioid overdose treatment.

Emergent BioSolutions, Inc

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New Zealand Could Become First Country To Offer Gout Drug Allopurinol OTC

 
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Trump Order To Improve Making More Drugs Available OTC Puts Wind Behind Petros’ ACNU Sails

 
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Petros will incorporate into its platform an analytics firm’s automated document capture and authentication system leveraging its global ID library to verify identity and eligibility of consumers accessing the self-selection process for an ACNU switch.

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Over The Counter: Taking Real-World Evidence Seriously, With IQVIA Consumer Health’s Volker Spitzer

 
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In part 2 of HBW Insight's interview, IQVIA Consumer Health's vice president of global research and development and real-world evidence services, Volker Spitzer, explains how to approach real world evidence so that regulators recognize its validity, in supporting Rx-to-OTC switch applications, for example.

Value Of Consumer Wearables Within The Clinic Currently Unknown, Says Cardiologist

 
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US FDA Expands Surprise Foreign Inspections

 
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Commissioner Martin Makary’s repeated characterization of foreign facilities as being subject to lower standards than domestic counterparts may have contributed to Rogers’ decision to retire as head of the recently formed Office of Inspections and Investigations.