Code intelligence

FDA-NDA207356 reimbursement alerts

Policy changes, MAC LCD updates, and CMS guidance referencing code FDA-NDA207356.

Critical code risk

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Risk: Critical
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Critical

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High

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Routine

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FDA Approval: ARIKAYCE (AMIKACIN) — Type 3 - New Dosage Form

Policy FDA-NDA207356 · Pulmonology

Critical

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 a