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FDA Has Model Drug Facts Labels For OTC Naloxone, Wants Switch Proposals

 
• By Malcolm Spicer

Development of the model DFLs was a first for agency, reflecting alarm over public health crisis of overdoses from opioid abuse, which reached nearly 48,000 in 2017. The project was "part of our broader commitment to addressing the opioid crisis" and should help sponsors with potential naloxone OTC switch NDAs, says Commissioner Scott Gottlieb.

FDA entrance sign 2016

FDA underscored its interest in proposals for allowing OTC access to naloxone for treating opioid overdose by taking the unprecedented step of developing model Drug Facts labels that potential sponsors can use for their own label comprehension studies.

The agency announced the release of the model DFLs on Jan. 17 along with publication of its review of independent research contractors' study of label comprehension for OTC use of...

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Over The Counter: Driving Innovation In France’s Self-Care Market, With NèreS’ Luc Besançon

 
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HBW Insight speaks to NèreS' executive director Luc Besançon about the key issues facing France's self-care industry, especially Rx-to-OTC switch and the revised Urban Wastewater Treatment Directive.

Allergy Ingredient Itch Warning, ACNU Final Rule Scratch Extent Of FDA Authority For Label Changes

 
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Effective date for ACNU OTC switch final rule and finding of severe itching from long-term use of common allergy ingredients are bookends for limits of FDA’s authority for product label changes.

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.

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

 
• By David Ridley

At the second attempt, New Zealand’s Medicines Classification Committee supported the Rx-to-OTC switch of allopurinol (100mg and 300mg) for people suffering from gout by specifically trained pharmacists.

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Galenica’s Verfora Gets Off To Flying Start In Swiss CHC Market

 
• By Tom Gallen

Verfora grows almost 10-times faster than the Swiss consumer health market in the opening months of 2025.

Review Suggests Advantage Of Bayer’s Iberogast Advance For Digestive Disorders

 
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Bayer's Iberogast Advance's combination of six herbal ingredients may produce a synergistic effect that acts on multiple underlying issues contributing to digestive disorders like functional dyspepsia (FD) and irritable bowel syndrome (IBS), a recently published study suggests.

FDA Draft Guidance Waves Green Flag On Changing Color Additives For Drugs In US

 
• By Malcolm Spicer

In a nod to drug manufacturers’ potential interest in moving to natural alternatives for petroleum-based synthetic dyes the agency intends to remove from use, document explains process for asking for approval for “any dye, pigment, or other substance that can impart color to a food, drug, cosmetic,