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LPAD As An Afterthought? Insmed’s Arikayce Reaches US Market Thanks To Limited Population Pathway

Executive Summary

Amikacin liposome inhalation suspension for the treatment of Mycobacterium avium complex lung disease is first antimicrobial approved under 21st Century Cures Act pathway; LPAD designation request appears to have occurred after an advisory committee recommended approval for more limited population than requested by Insmed.

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