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Primatene Mist NDA Expected By July After FDA OKs OTC Asthma Inhaler Trial

This article was originally published in The Pink Sheet & The Rose Sheet

Executive Summary

Amphastar plans this month to begin what it expects to be its final study to support an NDA to relaunch Primatene Mist. If the results support accurate self-selection and usage of the product by consumers, Amphastar should be ready to re-submit the NDA during the current quarter.

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