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Primatene OTC Asthma Inhaler Amended NDA Expected Second Quarter

This article was originally published in The Tan Sheet

Executive Summary

Amphastar Pharmaceuticals "recently received constructive comments from the FDA regarding our studies" and is "in the process of completing what we believe to be our final human factors study" before responding to a complete response letter the agency submitted in 2014, says company President Jason Shandell.

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