BLA 761062

AMGEN INC

FDA Drug Application

Application #761062

Documents

• Label: 2019-04-09
• Medication Guide: 2019-04-09
• Letter: 2019-04-10
• Review: 2019-05-16
• Label: 2019-12-23
• Letter: 2019-12-26

Application Sponsors

BLA 761062

AMGEN INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

105MG/1.17ML

0

EVENITY

ROMOSOZUMAB-AQQG

FDA Submissions

TYPE 1/4; Type 1 - New Molecular Entity and Type 4 - New Combination	ORIG	1	AP	2019-04-09	STANDARD
LABELING; Labeling	SUPPL	2	AP	2019-12-20	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15

CDER Filings

AMGEN INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761062
            [companyName] => AMGEN INC
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/761062s000lbl.pdf#page=19"]
            [products] => [{"drugName":"EVENITY","activeIngredients":"ROMOSOZUMAB-AQQG","strength":"105MG\/1.17ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"12\/20\/2019","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761062s002lbl.pdf\"}]","notes":""},{"actionDate":"04\/09\/2019","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761062s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"04\/09\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761062s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/761062Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/761062Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"12\/20\/2019","submission":"SUPPL-2","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761062s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/761062Orig1s002ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2019-12-20
        )

)