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Primatene Mist CRL Underscores Challenges For OTC Asthma Treatments

This article was originally published in The Pink Sheet

Executive Summary

Second FDA complete response letter for a reformulated Primatene Mist likely pushes back by another 18 months Amphastar's potential relaunch of the OTC product after satisfying the US agency's concerns about consumers correcting using the product without a doctor’s intervention.

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