GENZYME CORP FDA Approval BLA 761194

BLA 761194

GENZYME CORP

FDA Drug Application

Application #761194

Documents

Label2021-08-09
Letter2021-08-10
Review2021-09-07

Application Sponsors

BLA 761194GENZYME CORP

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION100MG0NEXVIAZYMEAVALGLUCOSIDASE ALFA-NGPT

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2021-08-06PRIORITY

Submissions Property Types

ORIG1Null6

CDER Filings

GENZYME CORP
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761194
            [companyName] => GENZYME CORP
            [docInserts] => ["",""]
            [products] => [{"drugName":"NEXVIAZYME","activeIngredients":"AVALGLUCOSIDASE ALFA-NGPT","strength":"100MG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"08\/06\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/761194s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"08\/06\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/761194s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/761194Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2021-08-06
        )

)

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