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Generated: January 23, 2019

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Details for New Drug Application (NDA): 207356

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NDA 207356 describes ARIKAYCE KIT, which is a drug marketed by Insmed Inc and is included in one NDA. It is available from one supplier. There are nine patents protecting this drug. Additional details are available on the ARIKAYCE KIT profile page.

The generic ingredient in ARIKAYCE KIT is amikacin sulfate. There are fifteen drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the amikacin sulfate profile page.
Summary for 207356
Tradename:ARIKAYCE KIT
Applicant:Insmed Inc
Ingredient:amikacin sulfate
Patents:9
Formulation / Manufacturing:see details
Pharmacology for NDA: 207356
Medical Subject Heading (MeSH) Categories for 207356
Suppliers and Packaging for NDA: 207356
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ARIKAYCE KIT amikacin sulfate SUSPENSION, LIPOSOMAL;INHALATION 207356 NDA Insmed Incorporated 71558-590 71558-590-28 28 VIAL in 1 CARTON (71558-590-28) > 8.4 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION, LIPOSOMAL;INHALATIONStrengthEQ 590MG BASE/8.4ML
Approval Date:Sep 28, 2018TE:RLD:Yes
Regulatory Exclusivity Expiration:Sep 28, 2025
Regulatory Exclusivity Use:TX OF MAC LUNG DISEASE IN ADULTS WITH LIMITED OR NO ALTERNATIVE TX OPTIONS AS PART OF A COMBO ANTIBACTERIAL DRUG REGIMEN WHO DO NOT ACHIEVE NEGATIVE SPUTUM CULTURES AFTER A MINIMUM OF 6 CONSECUTIVE MONTHS OF A MULTIDRUG BACKGROUND REGIMEN THERAPY
Patent:➤ Try a Free TrialPatent Expiration:Jun 6, 2025Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATING MYCOBACTERIUM AVIUM COMPLEX (MAC) LUNG DISEASE IN ADULTS AS PART OF A COMBINATION ANTIBACTERIAL DRUG REGIMEN
Patent:➤ Try a Free TrialPatent Expiration:Aug 15, 2028Product Flag?YSubstance Flag?Delist Request?

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