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ARIKAYCE KIT (nda207356)- (EQ 590MG BASE/8.4ML)

AMIKACIN SULFATE INSMED INC
EQ 590MG BASE/8.4ML
No Yes
2035-May-15 Expired
None None
2030-Sep-28 No
LIMITED POPULATION: ARIKAYCE is an aminoglycoside antibacterial indicated in adults who have limited or no alternative treatment options, for the treatment of Mycobacterium avium complex (MAC) lung disease as part of a combination antibacterial drug regimen in patients who do not achieve negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen therapy. As only limited clinical safety and effectiveness data for ARIKAYCE are currently available, reserve ARIKAYCE for use in adults who have limited or no alternative treatment options. This drug is indicated for use in a limited and specific population of patients.
0 0 0
Total Other Developers None
Drugs with Suitability No
EQ 590MG BASE/8.4ML ** ** - - -
NDA Sales Available Total Generic Sales Available
Yes 0
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country

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