BLA 761166

PHARMAESSENTIA CORP

FDA Drug Application

Application #761166

Documents

• Label: 2021-11-15
• Medication Guide: 2021-11-15
• Letter: 2021-11-16
• Review: 2021-12-13

Application Sponsors

BLA 761166

PHARMAESSENTIA CORP

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;SUBCUTANEOUS

500 MCG/ML

0

BESREMI

ROPEGINTERFERON ALFA-2B-NJFT

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity

ORIG

1

AP

2021-11-12

STANDARD

Submissions Property Types

ORIG

1

Null

15

CDER Filings

PHARMAESSENTIA CORP

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761166
            [companyName] => PHARMAESSENTIA CORP
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2021\/761166s000lbl.pdf#page=18"]
            [products] => [{"drugName":"BESREMI","activeIngredients":"ROPEGINTERFERON ALFA-2B-NJFT","strength":"500 MCG\/ML","dosageForm":"INJECTABLE;SUBCUTANEOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"11\/12\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/761166s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"11\/12\/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\\\/761166s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/761166Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2021-11-12
        )

)