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Sanofi Xyzal OTC Antihistamine Claims Lose Second Challenge In Six Months

This article was originally published in The Pink Sheet & The Rose Sheet

Executive Summary

Sanofi will modify claims in social media ads that its Xyzal Allergy 24HR antihistamine is 'twice as fast' as Bayer's s Claritin after the US National Advertising Division found the statement is not supported by head-to-head testing. NAD also recommended the firm discontinue the claim the product provides “relief that starts at hour 1 instead of hour 2.”

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Sanofi Clarifies Xyzal-Zyrtec Size Comparison, Outweighs J&J Calculation

National Advertising Division recommends Sanofi add "nearly" to claim that Xyzal Allergy 24HR is "as effective at half the size" of J&J's Zyrtec in a TV ad because 3D modeling comparing the products showed Xyzal tablet has 73-mm volume and a Zyrtec tablet's is 145.2 mm. Sanofi's evidence also supported referring to Xyzal's size would not mislead consumers to expect its drug has half the pharmaceutical dosage of Zyrtec.

Xyzal Claim To Match Zyrtec Efficacy At Half Dosage Dissolves In NAD Review

Claims that Sanofi's Xyzal 24 HR OTC product contains the same effectiveness as competitor Zyrtec but with half the medication fail a US

National Advertising Division review. NAD also recommended modifying claims suggesting Xyzal's pharmacological design confers a clinically meaningful benefit over Zyrtec.

Xyzal Switch Extends Sanofi Into OTC 24-Hour Children's Antihistamine

FDA approval of Xyzal Allergy 24HR enables Sanofi to compete in the once-daily OTC pediatric antihistamine space in the US.

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