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Experts Support Statin, Triptan, Sleep Aid Switches In New Paradigm

This article was originally published in The Tan Sheet

Executive Summary

The American Society of Health-System Pharmacists has opposed allowing OTC sales of statins, but would support a switch made with conditions of safe use required. A Philadelphia College of Pharmacy professor argues that patients are better served by obtaining pharmaceuticals from health care professionals than using “un-standardized” dietary supplements

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Antiquated Nebulizers Deliver Uneven Asthma Doses – FDA Reviewers

Hand-held rubber ball nebulizers are “antiquated” and deliver inconsistently measured doses, FDA reviewers say in briefing materials prepared for a Feb. 26 advisory committee meeting to discuss removing the devices from the OTC monograph.

Antiquated Nebulizers Deliver Uneven Asthma Doses – FDA Reviewers

Hand-held rubber ball nebulizers are “antiquated” and deliver inconsistently measured doses, FDA reviewers say in briefing materials prepared for a Feb. 26 advisory committee meeting to discuss removing the devices from the OTC monograph.

FDA Sketched NSURE Novel Switch Initiative In 2012

FDA clarified parameters for novel switches of drugs to OTC status, including protecting innovators from potentially unfair generic competition and stating that a behind-the-counter class is not being considered, but the year ended without clear signals on what could be the potential first novel switch candidate and when FDA expects to propose regulatory changes to facilitate switches under conditions of safe use.

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