On J&J Challenge, Review Finds Nothing Funny In Genexa’s ‘Real Ingredients’ Comparison To Tylenol
Genexa appeals NAD recommendations to stop using or modify claims that make up the core of its advertising to differentiate its products. NAD reviewed ad claims for Genexa kids’ Pain & Fever acetaminophen product on a challenge by J&J.
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Pharmacist groups’ representatives, in meeting with FDA officials, reiterate argument for greater role in access to OTCs through “additional conditions for nonprescription use.” Group not at meeting, American Society of Health-System Pharmacists, suggests “intermediate approach to nonprescription status.”
PhRMA captures tone of its comments saying “proposed rule might play an important role” in making more drugs available OTC. AAM also references gauntlet, saying proposed pathway “would, in theory, broaden the types of nonprescription drugs available to consumers.” CHPA discusses same concerns as well as additional questions for FDA.
Attention must be paid when withdrawal is for NDA approved in 1948 for brand synonymous with nonprescription pain relief, Bufferin. Even when FDA’s decision amounts to NDA database recordkeeping, withdrawal of application demands notice in US OTC space.