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Home » FDA Panel Endorses Insmed’s Lung Disease NDA for Narrow Indication
FDA Panel Endorses Insmed’s Lung Disease NDA for Narrow Indication
An FDA advisory committee voted Tuesday in favor of the safety and effectiveness of Insmed’s NDA amikacin for treatment of nontubercuolous mycobacterial (NTM) lung disease for patients with limited treatment options. But the panel rejected it for adult patients as a whole.