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Asthma Drug Petition Opposes OTC Approach, NSURE Paradigm

This article was originally published in The Pink Sheet Daily

Executive Summary

The developing Rx-to-nonprescription switch paradigm should exclude asthma and anaphylaxis drugs, advocates argue in a citizen petition. They say making inhalers available OTC contradicts the current standard for care.

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FDA’s Broad Power Can Overcome NSURE Labeling Obstacles – Attorney

Attorney Richard Kingham says the agency has authority to require broadly defined labeling for Rx-to-OTC switches, as well as to obligate generics to follow the same measures as innovator products. Consultant George Quesnelle says FDA’s openness to novel switch strategies on a case-by-case basis is key.

Extra-Label Communication Could Foster Novel Switch NDAs – Industry Attorney

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Nephron Launches Asthma Inhaler Into Wide Open OTC Market

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