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.
You may also be interested in...
Primatene Firm Expects Approval, Counts On Brand Equity, Target Market
Amphastar Pharmaceuticals expects FDA to approve an amended NDA for Primatene HFA in 2016. Executives with the firm say sales of breath-triggered Primatene HFA could exceed annual revenues from the original Primatene Mist metered-dose inhaler before it was pulled from the market in 2011.
Primatene Firm Expects Approval, Counts On Brand Equity, Target Market
Amphastar Pharmaceuticals expects FDA to approve an amended NDA for Primatene HFA in 2016. Executives with the firm say sales of breath-triggered Primatene HFA could exceed annual revenues from the original Primatene Mist metered-dose inhaler before it was pulled from the market in 2011.
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.