FDA-NDA207356
Document details
Summary
Arikayce (amikacin liposomal inhalation suspension) received FDA approval in September 2018 as an inhaled orphan drug for refractory Mycobacterium avium complex (MAC) lung disease, administered via aInhaled orphan antibiotic Arikayce bills under Medicare Part B.
Affected specialty
Pulmonology alerts →Source document
http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207356s000lbl.pdfCLV Intelligence summarizes publicly available federal publications. Not affiliated with or endorsed by any government agency.
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