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Asthma Drug Petition Opposes OTC Approach, NSURE Paradigm

This article was originally published in The Tan Sheet

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

FDA has several avenues to foster more novel Rx-to-OTC switches, including allowing extra-label communications beyond the packaging, similar to dispensing labeling used by a pharmacist, to be part of an approval.

Nephron Launches Asthma Inhaler Into Wide Open OTC Market

Nephron Pharmaceuticals makes its racepinephrine-containing Asthmanefrin, previously marketed only to health care professionals, available as the only OTC inhaler. The product likely will be alone on the market until Amphastar Pharmaceuticals’ planned launch in 2013 of a reformulated Primatene Mist inhaler.

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