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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...

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More from Rx-to-OTC Switch

EU Pharma Reform: Council Proposes Rx Exemption For Topical Antimicrobials

 
• By David Ridley

The EU Council has introduced a key amendment to Article 51 (para 1, point e) of the new pharma directive: “A medicinal product shall be subject to medical prescription where it is an antimicrobial, unless intended for topical use.”

AESGP Annual Meeting: Commission Must ‘Think Carefully’ Before Reverse-Switching Antimicrobials

 
• By David Ridley

If the European Commission is serious about improving the competitiveness of the European Union, it should ditch the idea of making commonly used OTC antimicrobials like thrush treatments and cold sore creams prescription-only, warns Greek Medicines Agency president Evangelos Manolopoulos

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

 
• By David Ridley

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

 
• By Malcolm Spicer

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.

More from Health

Germany’s PharmaSGP To Be Taken Private

 
• By Tom Gallen

Consumer health player PharmaSGP will be taken private by its biggest shareholder, FUTRUE.

FDA’s FY 2026 Budget Request Lacks New Policy Proposals

 
• By Sue Sutter

The White House requested $6.8bn for the FDA, down 3.9% from the current funding level, but does not propose any legislative changes. In previous years, the agency used the budget process to seek statutory fixes specific to generic drugs and shortages.

House Appropriators’ $3.2Bn For FDA In FY 2026 Includes More Non-User Fee Funds Than Requested

 
• By Sue Sutter and Derrick Gingery

A US House bill would give the FDA $33.1m more in budget authority than requested by the Trump Administration for fiscal year 2026. The measure was sent to the full House Appropriations committee on a party-line vote.