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Forest, Almirall LAMA/LABA needs CMC work; NDA submission delayed

This article was originally published in Scrip

Executive Summary

After having a chat with US regulators, Forest Laboratories and Almirall have decided to hold off for the time being on submitting a new drug application (NDA) to the FDA for the companies' combination chronic obstructive pulmonary disease (COPD) medicine, disclosing after the markets closed on 14 August the firms must first resolve some chemistry, manufacturing and control (CMC) specifications associated with the formulation.



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