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PSE Product Makes “Highly” Tamper-Resistant Claim With 100% Out Of Reach

This article was originally published in The Tan Sheet

Executive Summary

Westport Pharmaceuticals says a claim of being “highly” resistant to PSE-extraction distinguishes Zephrex-D from the competition, but the distinction alone is not adding up to market-share gains in the nonprescription nasal decongestant space.

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Extended-Release PSE Points Acura At First Tamper-Resistant Formulation NDA

Like extended-release PSE products already available OTC, a product with tamper-resistant formulation labeling must go through the NDA process. “The novelty of this to the FDA is what testing you do to demonstrate meth resistance … what labeling do you put on a product?” says Acura CEO Bob Jones.

Extended-Release PSE Points Acura At First Tamper-Resistant Formulation NDA

Like extended-release PSE products already available OTC, a product with tamper-resistant formulation labeling must go through the NDA process. “The novelty of this to the FDA is what testing you do to demonstrate meth resistance … what labeling do you put on a product?” says Acura CEO Bob Jones.

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