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First Green Light In US For ED Drug OTC Switch Actual Use Trial Goes To Opella For Cialis

ACNU Self-Selection Platform Becomes Full Focus Of US Firm Petros

 
• By Malcolm Spicer

Opella says FDA “lifted a clinical hold on its planned actual use trial to support the switch of Cialis” while Petros Pharmaceuticals shifts from working on its own ED-switch proposals to developing a proprietary technology-assisted platform designed for use in consumers’ self-selection of drugs made available in ACNU proposals.

(Source: Shutterstock)

The first US approval for an actual use trial for an OTC switch of an erectile dysfunction drug has gone to Sanofi’s consumer business, Opella, a move that could signal the first proposal the Food and Drug Administration will consider as an “additional conditions for nonprescription use” switch.

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• By Adam Zamecnik

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Over The Counter: Brands, Brexit And New Self-Care Business Models, With PAGB’s Michelle Riddalls

 
• By David Ridley

HBW Insight catches up with UK OTC industry association CEO Michelle Riddalls to talk about digital self-care and the unrealized promise of Brexit - part 2.

Preamble ‘Poison Pill’ Could Haunt ACNU Switch Rule – House Energy And Commerce Members

 
• By Malcolm Spicer

Reps. Latta, Crenshaw and Miller-Meeks contend language in ACNU final rule preamble would allow a sponsor of an approved application to litigate to halt Rx availability of same formulation and “risk eliminating the very rule on which its product approval was based.”

Over The Counter: Evolving The UK Consumer Health Industry, With PAGB’s Michelle Riddalls

 
• By David Ridley

HBW Insight catches up with PAGB CEO Michelle Riddalls to chat about the association's new five year plan. Riddalls also reflects on the successes of the last five years, including relaunching the UK Reclassification Alliance, which has published a list of Rx-to-OTC switches the government would like to see applications for. Part one of two.

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Astaxanthin Specialist AstaReal Diversifies With Garlic Supplement For Heart Health

 
• By Tom Gallen

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Little Industry Opposition To FDA Plan To Remove Synthetic Dyes, Or Agreement They’re Unsafe

 
• By Malcolm Spicer

Dyes and colors which FDA says industries agree should no longer be used aren’t unsafe and are currently used only with the agency’s approval, industry stakeholders say. Center for Science in the Public Interest says the dyes are used “in tens of thousands of foods and beverages that are commonly consumed here in the United States.”

NAD Refers Men’s Hair Color Brand To FTC For Non-Compliance With Fast-Track SWIFT Decision

 
• By Eileen Francis

Plano, Texas-based Simpler Hair Color Inc. may face FTC enforcement action after it failed to comply with the National Advertising Division’s recommendations it discontinue the claim, “Rated #1 Men’s Hair Color,” associated with a consumer review website.