NDA 207356

INSMED INC

FDA Drug Application

Application #207356

Documents

• Label: 2018-09-28
• Letter: 2018-10-10
• Review: 2019-05-20
• Label: 2020-03-16
• Medication Guide: 2020-03-16
• Letter: 2020-03-17
• Letter: 2020-10-21

Application Sponsors

NDA 207356

INSMED INC

Marketing Status

• Prescription: 001

Application Products

001

SUSPENSION, LIPOSOMAL;INHALATION

EQ 590MG BASE/8.4ML

1

ARIKAYCE KIT

AMIKACIN SULFATE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2018-09-28	PRIORITY
EFFICACY; Efficacy	SUPPL	3	AP	2020-10-19	STANDARD
LABELING; Labeling	SUPPL	4	AP	2020-03-13	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	7
SUPPL	4	Null	6

CDER Filings

INSMED INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207356
            [companyName] => INSMED INC
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/207356s004lbl.pdf#page=15"]
            [products] => [{"drugName":"ARIKAYCE KIT","activeIngredients":"AMIKACIN SULFATE","strength":"EQ 590MG BASE\/8.4ML","dosageForm":"SUSPENSION, LIPOSOMAL;INHALATION","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"03\/13\/2020","submission":"SUPPL-4","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/207356s004lbl.pdf\"}]","notes":""},{"actionDate":"03\/13\/2020","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/207356s004lbl.pdf\"}]","notes":""},{"actionDate":"09\/28\/2018","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/207356s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"09\/28\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"PRIORITY; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/207356s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/207356Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2018\\\/207356Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"03\/13\/2020","submission":"SUPPL-4","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/207356s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/207356Orig1s004ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2020-03-13
        )

)