BLA 761090

DYAX CORP.

FDA Drug Application

Application #761090

Documents

• Label: 2018-08-24
• Letter: 2018-09-18
• Review: 2018-09-20
• Label: 2018-11-20
• Letter: 2018-11-20
• Label: 2022-06-01

Application Sponsors

BLA 761090

DYAX CORP.

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	INJECTABLE;INJECTION	300MG/ML(150MG/ML)	0	TAKHZYRO	LANADELUMAB (SHP643)
002	SOLUTION;SUBCUTANEOUS	300MG/2ML (150MG/ML)	0	TAKHZYRO	LANDELUMAB-FLYO

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2018-08-23	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2022-02-08	N/A

Submissions Property Types

ORIG

1

Null

2

CDER Filings

DYAX CORP.

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(
    [0] => Array
        (
            [ApplNo] => 761090
            [companyName] => DYAX CORP.
            [docInserts] => ["",""]
            [products] => [{"drugName":"TAKHZYRO","activeIngredients":"LANADELUMAB (SHP643)","strength":"300MG\/ML(150MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"11\/16\/2018","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/761090s001lbl.pdf\"}]","notes":""},{"actionDate":"11\/16\/2018","submission":"SUPPL-1","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/761090s001lbl.pdf\"}]","notes":""},{"actionDate":"08\/23\/2018","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/761090s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"08\/23\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/761090s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/761090Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2018\\\/761090Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"11\/16\/2018","submission":"SUPPL-1","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/761090s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/761090Orig1s001ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2018-11-16
        )

)