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In GSK Challenge Of Salonpas Claims, NAD Embarks On Review Of Unchartered Argument

'Regulatory Review’ Claim For Salonpas Not A Comparison To Voltaren Approval

Executive Summary

Hisamitsu America’s severity of pain claims for Salonpas challenged by GSK are more nuanced than what label indications support, but touting its regulatory approval doesn’t convey a message that other products aren’t subject to as rigorous pre-market evaluations.

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Salonpas Spreads Into OTC Diclofenac Arthritis Gel

Hisamitsu America launches Salonpas Arthritis Pain Relief Gel with same active ingredient, diclofenac sodium 1% gel, that became available OTC for the first time in the US in 2020 with GSK’s Voltaren Arthritis Pain formulation.

US OTC Switch Drought Ends: FDA Approves GSK Arthritis Gel, Alcon Allergy Eye Drops

FDA approved sNDAs from GlaxoSmithKline for diclofenac-containing Voltaren Arthritis Pain for the temporary relief of arthritis pain and from Alcon for Pataday olopatadine drops at 0.2% concentration for once-daily use temporary relief of itchy eyes due to pollen, ragweed, grass, animal hair or dander and 0.1% for twice-daily use for the same indications plus redness relief.

With OTC Lidocaine, Salonpas Takes Path Of Less Resistance To Market

Hisamitsu America looked to the OTC lidocaine market after deciding it would have to wait too long for an ANDA approval for an Rx generic. "We really saw the opportunity in the OTC space with a 4% OTC patch," says President and CEO John Incledon.

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