BLA 761261

GENZYME CORP

FDA Drug Application

Application #761261

Documents

• Letter: 2022-09-01
• Label: 2022-09-01
• Review: 2022-09-13

Application Sponsors

BLA 761261

GENZYME CORP

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

20MG

0

XENPOZYME

OLIPUDASE ALFA-RPCP

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity

ORIG

1

AP

2022-08-31

PRIORITY

Submissions Property Types

ORIG

1

Null

7

CDER Filings

GENZYME CORP

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761261
            [companyName] => GENZYME CORP
            [docInserts] => ["",""]
            [products] => [{"drugName":"XENPOZYME","activeIngredients":"OLIPUDASE ALFA-RPCP","strength":"20MG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"08\/31\/2022","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/761261s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"08\/31\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/761261s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/761261Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2022-08-31
        )

)